Drug Delivery Devices

Abstract

The drug delivery device has a housing with a longitudinal axis, a dose setting member actuatable by a user and rotatable about the longitudinal axis to set a dose to be delivered by the drug delivery device, a piston rod configured to be advanced axially proximally to deliver the set dose, and a dispensing member for defining the axial advancement of the piston rod during delivery of the set dose. The dispensing member is axially movable along the longitudinal axis during dose setting and pivotally movable about the longitudinal axis, and the dispensing member is pivotally fixed to the dose setting member during dose setting. The dispensing member comprises a maximum dose stop configured to engage with a maximum stop feature provided on the housing to limit movement of the dispensing member relative to the housing during setting of the maximum dose.

Description

[Technical field]

[0001] The present disclosure relates to drug delivery devices. [Background technology]

[0002] Drug delivery devices, such as injection devices, are used in medical applications to deliver drugs, usually liquids, to a drug delivery site, such as an injection site. For applications where drug delivery needs to be performed multiple times, for example in emergency situations or within a relatively short time scale, such as in units of weeks, days or even hours, drug delivery devices have been developed that can be used by non-medically trained persons, such as patients, to self-administer the respective drug. Applications of such devices may include, for example, diabetes, hormone therapy, anticoagulant therapy, administration of adrenaline, etc. Among the known types of drug delivery devices that can be operated manually, semi-automatically or automatically to expel the drug from a drug compartment, pen-type devices have become very popular and, as a result, are now available in both reusable and disposable designs.

[0003] Disposable drug delivery devices are completely discarded when the drug compartment of the device is emptied to the extent that no further doses of drug can be expelled from the device. For single-use devices, the device is discarded after a single dose has been expelled, whereas multi-use devices allow for the repeated expulsion of several doses from the same drug container or drug compartment.

[0004] For reusable devices, the drug delivery device includes the possibility of resetting the delivery device so that the drug container can be replaced with a new one when the last dose has been delivered from the container. The emptying of the container as described above can occur after one dose ejection or after several dose ejections. The resetting can for example require moving the piston rod back into the housing of the device so that a new container can be attached to the device.

[0005] To define the amount of drug delivered, drug delivery devices are usually equipped with a dose-defining mechanism that is operable by the user of the device and defines a settable dose. To enable safe and error-free use of the device, e.g. to prevent inadvertent overdosing, it is necessary to ensure that the user is only allowed to set a dose within a limited range of settable doses. Furthermore, it is necessary to ensure that each set dose is precisely a predetermined amount of drug expelled from the device. Summary of the Invention

[0006] There is therefore a need to provide a dose delivery device that allows for precise and safe dose setting.

[0007] The present disclosure provides a drug delivery device as set forth in the independent claims. Embodiments are given in the dependent claims, the description and the drawings.

[0008] In a first aspect, the present disclosure is directed to a drug delivery device having a housing with a longitudinal axis, a dose setting member actuatable by a user and rotatable about the longitudinal axis to set a dose delivered by the drug delivery device, a piston rod configured to be advanced axially proximally to deliver the set dose, and a dispensing member for defining the axial advancement of the piston rod during delivery of the set dose. Thus, the dispensing member is axially movable along the longitudinal axis during dose setting and pivotally movable about the longitudinal axis, and the dispensing member is pivotally fixed to the dose setting member during dose setting. Furthermore, the dispensing member comprises a maximum dose stop, which is configured to engage with a maximum stop feature to limit movement of the dispensing member relative to the housing when the maximum dose is set. The maximum stop feature is provided on the housing.

[0009] The engagement between the maximum dose stop and the maximum stop feature allows the range of doses prescribable by the dispensing member to be reliably limited up to the maximum dose. By providing the maximum stop feature on the housing, a precise and robust reference position is established that prevents the upper limit from being exceeded, even if the user exerts significant force during dose setting.

[0010] The axial advance of the piston rod during delivery of the set dose may be directly proportional to the amount of drug delivered. Thus, by defining the axial advance of the piston rod, the set dose is also defined. For example, according to the drug delivery device according to the present disclosure, the piston rod may act against a piston that seals a cartridge containing the drug to be delivered, and the axial advance of the piston rod during delivery of the dose may be proportional to the amount of drug delivered.

[0011] During dose setting, the dosing member may be axially and / or rotationally movable relative to the housing of the drug delivery device. Engagement between a maximum dose stop and a maximum stop feature may, for example, limit the axial movement of the dosing member relative to the housing.

[0012] The maximum dose stop and the maximum stop feature may directly engage each other when setting the maximum dose. Alternatively, the maximum dose stop and the maximum stop feature may also only engage each other when the dose setting member has been pivoted a predetermined amount past a pivot position corresponding to the maximum dose.

[0013] According to one embodiment, the dosing member is pivotally movable relative to the dose setting member during dose delivery. This can, for example, prevent manipulation of the dose setting member during dose delivery from being translated into the dosing member and thus interfering with the drug delivery process. For example, the dose setting member can be prevented from pivoting relative to the housing during dose delivery, while the dosing member is configured to pivot relative to the housing to allow the set dose to be delivered.

[0014] The drug delivery device may for example comprise a clutch mechanism provided between the dose setting member and the dispensing member, which non-rotatably couples the dose setting member and the dispensing member during dose setting and decouples said members during dose delivery. The transition of the clutch mechanism from its coupled or closed state to its decoupled or open state can for example be affected by pressing an actuation member of the drug delivery device to start the dose delivery process.

[0015] According to one embodiment, the dosing member is configured to perform more than one full rotation relative to the housing during dose setting, such as at least two full rotations, for example the dosing member may be configured to perform two full rotations to set the maximum settable dose.

[0016] By not limiting the movement of the dosing member to at least one complete rotation, a large range of settable doses and / or closely spaced doses can be provided, allowing the dose regulation mechanism of the drug delivery device to be adapted to a wide range of applications.

[0017] According to one embodiment, the dosing member is threadedly connected to the housing, for example via an external thread provided on the dosing member and a corresponding internal thread provided on the housing. The threaded connection can then define the ratio between the axial and rotational movements of the dosing member during dose setting and / or dose delivery. By providing the housing of the drug delivery device with both the threaded connection and a maximum stop feature, the movement of the dosing member can be precisely and reliably limited.

[0018] According to one embodiment, the dosing member is rotatable relative to the housing during both dose setting and dose delivery: during dose setting, movement of the dosing member from its initial position to its final position can define the set dose, while thereafter, during dose delivery, movement of the dosing member from its final position back to its initial position effects the advancement of the piston rod and the expulsion of the drug from the device.

[0019] According to one embodiment, the maximum dose stop comprises a stop surface configured to axially abut against the maximum stop feature of the housing when the maximum dose is set. The maximum dose stop thus abuts against the maximum stop feature by moving parallel to the longitudinal axis of the device. This allows for a precise limiting of the axial movement of the dispensing member.

[0020] According to one embodiment, the stop surface is oriented perpendicular to the longitudinal axis. Thus, the axial position of the stop surface depends on the angular position about the longitudinal axis. As a result, the axial position of the dispensing member when hitting the maximum stop feature does not depend on the pivotal position of the dispensing member.

[0021] According to one embodiment, the stop surface is an annular surface surrounding the longitudinal axis, which ensures that the maximum dose stop engages the maximum stop feature regardless of the pivotal position of the dispensing member relative to the longitudinal axis.

[0022] Generally, the maximum stop feature may be configured to cover only limited angular positions about the longitudinal axis in a cross section perpendicular to the longitudinal axis. If the drug delivery device comprises several maximum stop features, the set of maximum stop features may be configured to cover only limited angular positions as well. Then, by configuring the stop surface as oriented perpendicular to the longitudinal axis and / or as an annular surface, the axial position of the administration member upon engagement with the maximum stop feature may be prevented from being dependent on its rotational position.

[0023] According to one embodiment, the maximum dose stop protrudes from the outer surface of the dispensing member, thus the position of the dispensing member upon engagement with the maximum stop feature can be flexibly designed by choosing the position of the maximum dose stop on the outer surface of the dispensing member.

[0024] According to one embodiment, the maximum stop feature protrudes from the inner surface of the housing. This allows the movement of the dispensing member to be stopped before it reaches the end of the housing. Furthermore, the position of the dispensing member upon engagement with the maximum stop feature can be flexibly designed by choosing the position of the maximum stop feature on the inner surface of the housing.

[0025] According to one embodiment, the maximum dose stop is spaced from the distal end of the dosing member, which allows for providing additional space at the end of the dosing member for engagement with other components of the drug delivery device, such as, for example, components providing the clutch mechanism of the device and / or components transmitting axial forces to the dosing member.

[0026] According to one embodiment, the maximum stop feature of the housing has a limiting surface oriented perpendicular to the longitudinal axis, with which the maximum dose stop engages upon setting of the maximum dose. The limiting surface may, for example, be oriented perpendicular to the longitudinal axis. The limiting surface may, for example, be configured as a flat surface.

[0027] According to one embodiment, the maximum stop feature of the housing is provided on a flexible element that is configured to snap-fit ​​over the maximum dose stop of the dosing member upon assembly of the drug delivery device, thereby allowing easy assembly of the device.

[0028] The flexible element may be configured to snap over the maximum dose stop when, during use, the dosing element is moved proximally relative to the housing and / or in a direction corresponding to a reduction in the set dose.

[0029] According to one embodiment, the flexible element rests against a backing element, such as an outer housing surrounding the inner housing with the flexible element, to prevent the maximum stop feature from disengaging from the maximum dose stop after assembly of the drug delivery device, thereby ensuring that the movement of the dosing member is positively stopped when engaging the maximum stop feature.

[0030] According to one embodiment, the dispensing member is configured as a dose indicating member providing the user with a visual indication of the set dose, e.g. via a corresponding optical marker on the outer surface of the dispensing member. As a result of limiting the movement of the dose indicating member during dose setting by equipping the dispensing member with a maximum dose stop, the set dose is precisely indicated, e.g. the setting of a maximum dose is precisely indicated.

[0031] According to one embodiment, the dose setting member is configured to move axially relative to the housing together with the dispensing member during dose setting. Such axial movement of the dose setting member can provide tactile feedback to the user of the device and thus assist visually impaired users. Furthermore, it becomes possible to configure the dose setting member as an actuation member configured to be pushed back by the user of the device to cause the drug to be delivered.

[0032] According to one embodiment, the dispensing member comprises a zero dose stop, which is configured to engage with a zero stop feature to limit the movement of the dispensing member relative to the housing when the dispensing member reaches the zero dose position, the zero stop feature being provided on the housing. By defining the zero dose position via engagement between the dispensing member and the housing, the zero dose position is provided as a clearly defined reference position. This ensures precise definition of the amount of drug corresponding to the individual dose setting, thus preventing inadvertent under- or overdosing.

[0033] According to one embodiment, the zero dose stop engages with the zero stop feature in a contact plane that is angled with respect to a radial plane perpendicular to the longitudinal axis. Thus, the contact plane can be oriented perpendicular to the radial plane. Such a contact plane provides a precision zero dose stop mechanism that is configured to receive relatively large forces. When engaging with each other, the zero stop feature and the zero dose stop can move perpendicular to the radial plane and contact each other face-on.

[0034] According to one embodiment, the zero dose stop of the dispensing member comprises a stop surface configured to abut against a corresponding stop surface of the housing. The stop surfaces may be oriented parallel to one another. Additionally or alternatively, the stop surfaces may be configured as flat surfaces. The stop surfaces on both the zero dose stop and the housing allow for efficient force absorption when the dispensing member is reaching the zero dose position.

[0035] According to one embodiment, a zero dose stop is provided at the proximal end of the dispensing member, such zero dose stop being easily engageable by the zero stop feature as the dispensing member moves proximally towards the zero dose position.

[0036] According to one embodiment, the zero stop feature is provided at a proximal end of the housing cavity of the housing, such zero stop feature being readily engageable by the zero dose stop as the dispensing member moves proximally towards the zero dose position.

[0037] According to one embodiment, the zero stop feature and the maximum stop feature are provided on the same structural element of the housing, for example on the inner housing. This allows precisely defining the position of the dosing member where it engages with the corresponding stop feature. As a result, the axial distance travelled by the dosing member between the stop features, and therefore also the amount of drug corresponding to an individual dose setting, is precisely defined.

[0038] According to one embodiment, the structural element comprises a dose thread that threadably engages with the dosing member. The structural element can therefore also define the axial and rotational positions of the dosing member that correspond to the individual dose settings. This further enhances the reliability and reproducibility of the dose setting and dose delivery.

[0039] According to one embodiment, the structural element comprises a drive thread that threadably engages with a driver of the drug delivery device, the driver being coupled to the piston rod during dose delivery for axially advancing the piston rod upon axial movement of the driver. By providing both the stop feature and the drive thread on the same structural element, the axial distance traveled by the piston rod during dose delivery is precisely coupled to the axial position of the dosing member, thus providing high dose accuracy.

[0040] According to one embodiment, the drug delivery device comprises a dose setting mechanism for defining a rotational dose position of the dose setting member relative to the housing, the dose setting member being connected to the housing via a dose selector member, whereby the dose selector member is rotationally fixed relative to the housing and axially movable relative to the housing, the dose setting mechanism acting between the dose selector member and the dose setting member. Such a dose selector member allows the rotational positions of the dosing member corresponding to the individual settable doses to be defined directly on the dosing member itself, thus allowing the drug delivery device to be constructed simply and yet robustly. Due to the axial mobility of the dose selector member, the individual doses can be defined regardless of the axial position of the dose setting member during dose setting.

[0041] The dose selector member may be provided axially between the dosing member and the dose setting member. Furthermore, the dose selector member may be configured to transmit an axial force from the actuation member of the drug delivery device to the dosing member during dose delivery. The actuation member may be configured to be pushed by a user of the device to perform dose delivery. Generally, the actuation member may be the dose selector member or a separate member, such as, for example, a push button.

[0042] According to one embodiment, the dose selector member is axially fixed relative to the dispensing member, which allows for an efficient transmission of axial forces from the dose selector member to the dispensing member.

[0043] According to one embodiment, the dose selector member is connected to the housing via a connection that allows the dose selector member to be mounted to the housing only in a rotational orientation that ensures that the dose setting member is set to a dose position upon engagement of the maximum dose stop with the maximum stop feature, e.g. the connection only allows for a single rotational orientation, which facilitates assembly of the drug delivery device.

[0044] According to one embodiment, the connection comprises a spline connection that allows axial movement and prevents rotational movement of the dose selector member relative to the housing, the spline connection comprising a set of coding splines, the coding splines having respective dimensions, e.g. width and / or height, that differ from each other. Such a connection integrates both the coding function and the constraint of relative mobility between the dose selector member and the housing in the same structural element. This allows a simple and cost-effective construction of the drug delivery device.

[0045] According to one embodiment, a spline connection includes a single coding spline that is different from the remaining splines of the connection. Such a connection is simple in structure but nevertheless allows for a reliable coding function.

[0046] According to one embodiment, the dosing member is coupled to the piston rod via an advancing mechanism that converts an axial movement of the dosing member during dose delivery into an axial advancement of the piston rod, such that an axial movement of the dosing member during dose delivery advances the piston rod axially in the proximal direction. Such an advancing mechanism may, for example, comprise one or several additional members of the drug delivery device.

[0047] According to a drug delivery device according to the present disclosure, the advancement mechanism may include, for example, a driver and a nut, whereby the driver is coupled between the administration member and the nut, while the nut is coupled between the driver and the piston rod.

[0048] According to one embodiment, the advancement mechanism is configured as a gearing mechanism that reduces the axial movement of the administration member to a smaller axial advancement of the piston rod. As a result, the axial force applied to the administration member is converted by the piston rod into a larger axial force, for example, exerted by the plunger sealing the cartridge containing the drug to be delivered. This allows the drug to be easily delivered regardless of the viscosity of the drug.

[0049] According to one embodiment, the piston rod is pivotally fixed relative to the housing and the advancement mechanism comprises a nut coupled between the piston rod and the dispensing member, whereby the nut is threadably connected to the piston rod, during dose setting the nut is pivotally fixed relative to the dispensing member and pivotable relative to the housing, and further the nut is pivotable relative to the dispensing member and pivotable relative to the housing during dose delivery.

[0050] Such a construction of the advancement mechanism allows the nut and the dosing member to rotate simultaneously during dose setting, thus allowing both the nut and the dosing member to move axially relative to the housing and the piston rod. By fixing the nut rotatably relative to the piston rod during dose delivery, it is ensured that both the nut and the piston rod, which are threadably engaged with each other but are not allowed to rotate relative to each other, move in unison along the longitudinal axis. Thus, the nut can return to the same position relative to the housing after each dose delivery, while the piston rod is moved incrementally along the longitudinal axis with each dose delivery.

[0051] According to one embodiment, the advancement mechanism comprises a driver coupled between the nut and the dosing member, the driver being pivotally fixed to the dosing member and axially movable relative to the dosing member during both dose setting and dose delivery. The driver is further threadably coupled to the housing and configured to engage with the nut during dose delivery in order to axially advance the nut and the piston rod when rotated by the dosing member. Such a driver allows the implementation of a gearing mechanism with a gear ratio determined by the pitch of the threaded connection between the driver and the housing and the pitch of a further threaded connection between the dosing member and the housing.

[0052] A drug delivery device according to the present disclosure does not necessarily have to have a maximum dose stop with a maximum stop feature provided on the housing and a maximum dose stop provided on the dispensing member in order to reliably regulate the axial progression of the dispensing member during dose delivery and thus enable precise and safe dose setting and delivery. According to the present disclosure, a reliable regulation of the axial progression of the dispensing member is also achieved by providing a zero dose stop acting directly between the housing and the dispensing member.

[0053] Thus, in a second aspect, the present disclosure is directed to a drug delivery device having a housing with a longitudinal axis, a dose setting member actuatable by a user and rotatable about the longitudinal axis to set a dose delivered by the drug delivery device, a piston rod configured to be advanced axially proximally to deliver the set dose, and a dispensing member for defining the axial advancement of the piston rod during delivery of the set dose. The dispensing member is axially movable along the longitudinal axis during dose setting and is rotatably movable about the longitudinal axis. Furthermore, the dispensing member is rotatably fixed to the dose setting member during dose setting. The dispensing member comprises a zero dose stop configured to engage with the zero stop feature to limit the movement of the dispensing member relative to the housing during setting of the zero dose, the zero stop feature being provided on the housing.

[0054] The drug delivery device according to the second aspect of the present disclosure may be further configured as disclosed in relation to the drug delivery device according to the first aspect of the present disclosure, and vice versa. Thus, all embodiments and technical effects disclosed in relation to the drug delivery device according to the first aspect of the present disclosure also apply to the drug delivery device according to the second aspect, and vice versa.

[0055] In a third aspect, the present disclosure is directed to a drug delivery device having a housing with a longitudinal axis, a dose setting member actuatable by a user and rotatable about the longitudinal axis to set a dose delivered by the drug delivery device, a piston rod configured to be advanced axially proximally to deliver the set dose, and a dosing member for defining an axial advancement of the piston rod during delivery of the set dose, whereby the dosing member is axially movable along the longitudinal axis during dose setting, is pivotally movable about the longitudinal axis, and is pivotally fixed to the dose setting member during dose setting. The dose setting member is connected to the housing via a dose selector member, whereby the dose selector member is pivotally fixed relative to the housing and axially movable. The drug delivery device further comprises a dose defining mechanism for defining a pivotal dose position of the dose setting member relative to the housing, whereby the dose defining mechanism acts between the dose selector member and the dose setting member.

[0056] A dose setting mechanism with such a dose selector member allows the rotational positions of the dosing member corresponding to the individual settable doses to be defined directly on the dosing member itself, and thus the drug delivery device can be constructed simply and yet robustly. Due to the axial mobility of the dose selector member, individual doses can be defined regardless of the axial position of the dose setting member during dose setting.

[0057] The dose setting member may be axially movable relative to the dose selector member and / or the dose selector member may be axially fixed relative to the dispensing member.

[0058] The drug delivery device according to the third aspect of the present disclosure may be further configured as disclosed in relation to the drug delivery device according to the first and / or second aspect of the present disclosure, and vice versa. Thus, all embodiments and technical effects disclosed in relation to the drug delivery device according to the first and / or second aspect of the present disclosure also apply to the drug delivery device according to the third aspect, and vice versa.

[0059] According to all drug delivery devices according to the present disclosure, the medication stored within the cartridge of the device may be selected from the group of members consisting of diabetes medications such as insulin, growth hormones, reproductive hormones, osteoporosis medications, anticoagulants such as heparin, and medications for migraine headaches, HIV-associated nephropathy, non-alcoholic fatty liver disease or obesity.

[0060] Exemplary embodiments and features of the present disclosure are described herein in conjunction with the accompanying drawings, which generally show: [Brief description of the drawings]

[0061] [Figure 1] FIG. 1 is a perspective view of a drug delivery device according to the present disclosure with a cap attached. [Diagram 2] FIG. 1 is a perspective view of a drug delivery device with the cap removed and a dispensing unit attached. [Diagram 3] FIG. 1 is a perspective view of a drug delivery device, a cap and a dispensing unit. [Figure 4] FIG. 1 is a side view of a dispensing unit comprising a cartridge holder, a cartridge, and a needle attachable to the dispensing unit. [Diagram 5] FIG. 2 is a longitudinal cross-sectional view of a drug delivery device, a dispensing unit and a cap through a first cross section, the drug delivery device being in a dose setting state. [Figure 6] A longitudinal cross-sectional view of the drug delivery device, the first dispensing unit and the cap through a second cross-section perpendicular to the first cross-section, with the drug delivery device in a dose setting state. [Figure 7] FIG. 2 is an exploded partial view of the administration mechanism of the drug delivery device. [Figure 8] FIG. 2 shows a longitudinal cross-sectional view of the dosing mechanism of the drug delivery device through a first cross-section, prior to setting a dose. [Figure 9] A longitudinal cross-sectional view of the administration mechanism through a first cross section after setting a dose, with the administration mechanism in a dose setting state. [Figure 10] FIG. 2 shows a longitudinal cross-section of the administration mechanism through a first cross-section after setting a dose, with the administration mechanism in a dose delivery state. [Figure 11] A longitudinal cross-sectional view of the administration mechanism through a first cross section after delivering a dose, with the administration mechanism in a dose setting state. [Figure 12] FIG. 13 shows the clutch mechanism of the dosing mechanism in the dose setting state. [Figure 13] FIG. 13 is a diagram of the clutch mechanism in the dose delivery state. [Figure 14] FIG. 2 is a radial cross-section through the dose regulation mechanism of the drug delivery device. [Figure 15] FIG. 2 is a perspective view of the proximal side of a dose setting member of a drug delivery device. [Figure 16] FIG. 2 is a perspective view of the distal side of a clutch member of the drug delivery device. [Figure 17] FIG. 2 is a perspective view of the proximal side of the clutch member of the drug delivery device. [Figure 18] FIG. 2 shows a longitudinal section through the dosing member and the dose selector member of a drug delivery device having a first friction reducing mechanism. [Figure 19] FIG. 13 is a perspective view of a connection between a nut and a driver of a drug delivery device having a second friction reduction mechanism. [Figure 20] FIG. 2 is a perspective view of a dosing member of a drug delivery device; [Figure 21] FIG. 2 is a longitudinal cross-sectional view through the inner housing of the drug delivery device. [Figure 22] FIG. 2 is a perspective view of the inner housing with the dispensing member in the zero dose position. [Figure 23] FIG. 2 is a perspective view of the inner housing with the dispensing member in a maximum dose position. [Figure 24] FIG. 2 is a longitudinal cross-sectional view through the outer housing of the drug delivery device. [Diagram 25] FIG. 2 is a longitudinal cross-sectional view through an inner housing mounted within an outer housing of a drug delivery device. [Figure 26] FIG. 2 is a radial cross-sectional view through the outer and inner housings of a drug delivery device. [Figure 27] FIG. 2 is an exploded partial view of the reset mechanism of the drug delivery device. [Figure 28] FIG. 13 is a longitudinal cross-sectional view through the reset mechanism of the drug delivery device with the reset element in a proximal position. [Figure 29] FIG. 13 is a distal perspective view of a reset element of the reset mechanism. [Diagram 30] FIG. 13 is a proximal perspective view of a reset element. [Diagram 31] FIG. 13 is a proximal perspective view of the coupling portion of the reset mechanism. [Diagram 32] FIG. 2 is a perspective view of a coupling portion and an inner housing. [Diagram 33] FIG. 13 is a longitudinal section through the reset mechanism with the dispensing unit attached to the drug delivery device and the reset element located at a distal position. [Diagram 34] FIG. 1 shows a longitudinal cross-section through the proximal end of a cartridge holder that can be attached to a drug delivery device. [Diagram 35] FIG. 13 is a perspective distal view of a radial cross section through a proximal portion of the cartridge holder. [Diagram 36]1A and 1B show longitudinal cross sections through a first distribution unit that can be attached to a first drug delivery device, a second distribution unit that can be attached to a second drug delivery device, and a third distribution unit that can be attached to a third drug delivery device. [Figure 37] A longitudinal cross-section through a first connecting means of a first drug delivery device and an oblique view of the first connecting means, a longitudinal cross-section through a second connecting means of a second drug delivery device and an oblique view of the second connecting means, and a longitudinal cross-section through a third connecting means of a third drug delivery device and an oblique view of the third connecting means. [Figure 38] 1 is a perspective view of a further drug delivery device according to the present disclosure; [Figure 39] FIG. 2 is a diagram of a further drug delivery device with the cap removed. [Diagram 40] FIG. 13 is an exploded view of a further drug delivery device. [Diagram 41] FIG. 13 is a diagram of a clutch mechanism of a further drug delivery device. [Diagram 42] FIG. 13 is a diagram of a dose setting member of a further drug delivery device. [Diagram 43] FIG. 13 is a diagram of a dose selector member of a further drug delivery device. [Diagram 44] 13A-13C are diagrams of alternative embodiments of a reset element of a drug delivery device. [Diagram 45] 11A-11C are longitudinal cross-sectional views through alternative embodiments of a reset element. [Figure 46] FIG. 13 is an illustration of an alternative embodiment of a coupling portion of a drug delivery device. [Figure 47] 13A-13C are diagrams of an alternative embodiment of a reset element and an alternative embodiment of a coupling portion mounted to an alternative embodiment of an inner housing of a drug delivery device. [Figure 48] FIG. 13 is a perspective view of an alternative connection between a further alternative embodiment of the inner housing and an alternative embodiment of the dose selector member. [Figure 49]FIG. 13 is a longitudinal cross-sectional view through a further alternative embodiment of the inner housing and an alternative embodiment of the dose selector member. [Figure 50] FIG. 13 shows an alternative embodiment of the inner housing, the dose selector member and the dispensing member, with the dispensing member in the zero dose position. [Figure 51] FIG. 13 shows an alternative embodiment of the inner housing, the dose selector member and the dispensing member, with the dispensing member in a maximum dose position. [Figure 52] 11A-11C are views of an alternative embodiment of a clutch member. [Diagram 53] 13A-13C are diagrams of a drug delivery device having a further alternative embodiment of an inner housing, in which the counterweight is located on the outer surface of the inner housing. [Figure 54] FIG. 2 is a radial cross-section perpendicular to the longitudinal axis through a drug delivery device having a counterweight. [Figure 55] 13A-13C are views of an alternative embodiment of the inner housing. [Figure 56] FIG. [Figure 57] FIG. 13 is a radial cross-sectional view perpendicular to the longitudinal axis through an alternative embodiment of a drug delivery device having a counterweight. [Figure 58] FIG. 11 is a longitudinal cross-section through the first distribution unit, the second distribution unit, and the third distribution unit showing additional dimensions. [Figure 59] A longitudinal section through the first connecting means, the second connecting means and the third connecting means of a first drug delivery device, a second drug delivery device and a third drug delivery device, showing additional dimensions, and a perspective view of the first connecting means, the second connecting means and the third connecting means. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0062] In this disclosure, the term "distal portion / end" refers to the portion / end of a device, or a portion / end of a component or member of said device, that is located furthest from a patient's delivery / infusion site, according to the use of the device. Correspondingly, the term "proximal portion / end" refers to the portion / end of a device, or a portion / end of a component or member of said device, that is closest to a patient's delivery / infusion site, according to the use of the device. The proximal direction is oriented toward the delivery / infusion site, and the distal direction is oriented away from the delivery / infusion site.

[0063] The present disclosure of the reset mechanism is applicable with a number of medication delivery devices, for example, injection devices. One possible injection device is a pen design, illustrated in FIG.

[0064] 1 shows a drug delivery device 200 with a connection means for attaching a dispensing unit according to the present disclosure. The drug delivery device 200 has a generally tubular housing 210 that is elongated along a longitudinal axis 207. A generally tubular cap 209 is attached to a proximal end 205 of the housing 210. At a distal end 206 of the housing 210, the drug delivery device 200 comprises a dose setting member 290, the distal end 206 being located opposite the proximal end 205 along the longitudinal axis 207.

[0065] The dose setting member 290 is rotatable about the longitudinal axis 207 and is configured to be gripped and rotated by a user of the device 200 in order to set the dose delivered by the device 200. In this manner, the dose setting member 290 can also be considered as a knob or the like. In the embodiment shown in FIG. 1, the dose setting member 290 is configured as a knob that terminates the drug delivery device 200 at its distal end 206. According to other embodiments, the dose setting member 290 may also be configured as, for example, a rotatable sleeve or ring surrounding the longitudinal axis 207.

[0066] The dose setting member 290 is pivotally locked relative to the housing 210 during both dose setting and dose delivery and is connected to the housing 210 via an axially movable dose selector member 310. When the dose setting member 290 is rotated relative to the housing 210 and the dose selector member 310 to increase the set dose, the dose selector member 310 moves distally from the housing 210 and thus the dose setting member 290 also moves in the distal direction.

[0067] The housing 210 comprises an outer housing 211, which in this embodiment is made from metal, and an inner housing 180. The inner housing 180 is located within the outer housing 211. In this embodiment, the inner housing is made from a plastic material. The housing 210 comprises a window, which is formed by a window 211a in the outer housing 211, through which a portion of the inner housing 180 and a window 180a in the inner housing 180 are visible to a user of the device 200. Through the window in the housing 210, a dose indicating member 330, which is located inside the housing 210, i.e., inside the generally tubular inner housing 180, is visible to a user.

[0068] The dose indicating member 330 is also configured as a generally tubular member and carries on its cylindrical outer surface a dose scale including a number of optical markers 331 corresponding to respective set doses. When setting a dose, the dose indicating member 330 rotates within the inner housing 180, which changes the scale visible through the windows 211a and 180a, and therefore the position of the optical markers 331.

[0069] 2 shows the drug delivery device 200 with the cap 209 removed. A dispensing unit 410 containing the drug to be delivered by the device 200 is removably attached to the proximal end 205 of the housing 210. FIG 3 shows the cap 209 and dispensing unit 410 removed from the drug delivery device 200. The cap 209 and dispensing unit 410 are attached to the housing 210 of the device 200 such that the dispensing unit 410 is fully received within the cap 209.

[0070] The dispensing unit 410 comprises a cartridge holder 412, which in the present embodiment is made of a plastic material. The cartridge holder 412 may be formed, for example, by injection molding. The cartridge holder 412 attaches to the outer housing 211 of the drug delivery device 200 via a connection, which includes a first connection means 510 located at the proximal end of the housing 210 and a corresponding first connection means 414 located at the distal end of the dispensing unit 410. The first connection means 510 of the housing 210 is formed as an integral part of the housing 210, i.e. as an integral part of the outer housing 211, and the first connection means 414 of the dispensing unit 410 is formed as an integral part of the cartridge holder 412.

[0071] At its proximal end, the cartridge holder 412 of the dispensing unit 410 comprises a needle connector 402 configured to receive a hollow needle or cannula through which the drug is delivered by the drug delivery device 200. In this embodiment, the needle connector 402 is configured as a threaded connector. According to other embodiments, the needle connector 402 may also be configured as, for example, a snap-fit, bayonet or Luer Lock™ connection.

[0072] FIG. 4 shows a cartridge holder 412 of a dispensing unit 410 and a cartridge 8 that can be inserted into the cartridge holder 412 , as well as a needle 4 that can be attached to a needle connector 402 .

[0073] The cartridge 8 has a generally cylindrical body, in this embodiment made from glass, enclosing a drug compartment 81 containing the liquid drug to be delivered by the drug delivery device 200. The drug compartment 81 is sealed at its distal end by an elastic plunger 9 which is movable along the longitudinal axis within the body of the cartridge 8. At its proximal end, the cartridge 8 comprises an annular rim 82 which is separated from the body by an annular detent 85 located distally from the annular rim 82. At its proximal front face of the cartridge 8, which is oriented perpendicular to the longitudinal axis 207, the cartridge 8 comprises a sealing means or septum 8a which seals the drug compartment 81 in the proximal direction.

[0074] When fully inserted into the cartridge holder 412, the sealing means 8a is located at the proximal end of the cartridge holder 412 and is accessible through an opening at the proximal end of the cartridge holder 412. The cartridge 8 is non-releasably held in the cartridge insertion position by the connector 404. The connector 404 is configured as a flexible member. In this embodiment, the connector is configured as a snap hook. The connector 404 is formed by a cut-out portion of the cartridge holder 412. When the cartridge 8 is inserted into the cartridge holder 412, the connector 404 snaps onto the annular rim 82 of the cartridge 8. A radially inwardly protruding finger of the connector 404 then lies in the annular detent 85 of the cartridge 8 and abuts against the distal surface 83 of the annular rim 82, thereby preventing distal movement of the cartridge 8.

[0075] This non-releasable connection between the cartridge 8 and the cartridge holder 412 prevents the cartridge 8 from being removed from the cartridge holder 412 during intended use of the dispensing unit 410. For example, this connection prevents the cartridge 8 from being removed unless the connector 404 is intentionally and / or forcefully pulled out of engagement with the annular rim 82. The non-releasable connection is thus configured such that such disengagement is only possible using a tool or using an excess force that is stronger than the force acting on the non-releasable connection during normal and / or intended use of the dispensing unit 410, for example during loading of the dispensing unit 410 into the housing 210, during attachment of the needle 4 to the cartridge holder 412, or during handling of the dispensing unit 410 with the cartridge 8 inserted into the cartridge holder 412. This handling may also include impact forces that may occur during transportation and / or unintentional dropping of the dispensing unit, which do not exert forces that would destroy the dispensing unit 410 and / or the cartridge holder 412 and / or the cartridge 8. The non-releasable connection between the cartridge 8 and the cartridge holder 412 allows the dispensing unit 410 with the cartridge 8 inserted to be offered and sold as a single pre-loaded unit.

[0076] The needle 4 is configured as a pen needle. It comprises a hub 5 carrying a double-ended cannula 6. The cannula 6 is received in the hub 5 in a longitudinal direction. The hub 5 comprises a hub connector at its distal end that matches the needle connector 402 of the cartridge holder 412. In this embodiment, the hub connector is configured as an internal thread that matches the external thread of the needle connector 402. The cannula 6 protrudes from the proximal end of the hub 5. The cannula has sharpened ends at both its proximal and distal ends. By its distal end, the cannula 6 pierces the sealing means 8a of the cartridge 8, thus establishing a fluid connection between the drug compartment 81 and the proximal end of the cannula 6. The proximal end of the cannula 6 is configured to be inserted into a delivery site, such as the skin of a user of the device 200, thus allowing the injection of a drug into the delivery site.

[0077] Figures 5 and 6 show longitudinal sections through the drug delivery device 200 along two different cross sections that are oriented perpendicular to each other. Figure 7 shows a partially exploded view of the components of the drug delivery device 200 seen in Figures 5 and 6. The drug delivery device 200 comprises a dosing mechanism 230 configured to set a dose of drug to be delivered by the drug delivery device 200 and to expel the set dose by moving the plunger 9 in a proximal direction.

[0078] The dosing mechanism 230 comprises a piston rod assembly having a piston rod 240 elongated along the longitudinal axis 207 and a plunger disc 242 (see Figs. 5 and 6) mounted at a proximal end of the piston rod 240. The piston rod assembly is configured to directly contact the plunger 9 by means of the plunger disc 242 and advance the plunger 9 within the cartridge 8 upon proximal movement of the piston rod assembly. The piston rod 240 has a non-circular cross section and an external thread 241 covering essentially the entire length of the piston rod. At its proximal end, the piston rod 240 comprises a disc connector 244 for receiving the plunger disc 242. At its distal end, the piston rod 240 comprises a stop feature 243 terminating the external thread 241 and exemplarily configured as a thickened portion of the piston rod 240 having a radial extension greater than the minor diameter of the thread 241.

[0079] The piston rod 240 is located in the housing 210, i.e. in the outer housing 211 and the inner housing 180. In use, the piston rod 240 can protrude from the proximal end of the housing 210, so that the plunger disk 242 can be moved completely out of the housing 210 and into the cartridge 8. The piston rod 240 always protrudes from the proximal end of the inner housing 180. The piston rod can be fully retracted into the outer housing 211, for example, after a reset and / or before and / or immediately after attaching a new dispensing unit 410 to the device 200. During use of the device 200, the piston rod 240 is moved proximally and also protrudes from the outer housing 211. The plunger disk 242 is permanently located outside the inner housing 180 and can be fully retracted into the outer housing 211, for example, after completion of a reset operation and / or before and / or immediately after attaching a new dispensing unit 410 to the device 200.

[0080] The piston rod 240 is pivotally locked relative to the housing 210 during both dose setting and dose delivery. In this embodiment, the piston rod 240 is connected to the housing 210 via a reset element 110 of the reset mechanism 100 of the drug delivery device 200. See Figs. 5 and 6. The reset element 110 is pivotally fixed relative to the housing 210 during both dose delivery and dose setting. The reset element comprises a longitudinal opening 114 for receiving the piston rod 240, such that the plunger disk 242 is located proximal to the opening 114 and the stop feature 243 is located distal to the opening 114. The opening 114 is configured as a through hole having a non-circular cross-section that matches the non-circular cross-section of the piston rod 240, thereby allowing axial movement but preventing rotational movement of the piston rod 240 relative to the reset element 110.

[0081] The piston rod 240 is surrounded by a hollow, generally cylindrical nut 250. The nut 250 is threadedly engaged with the threads 241 of the piston rod 240. In this embodiment, the nut 250 includes a threaded section having an internal thread 256 that engages with the external threads 241 of the piston rod 240. The threaded section is located in a proximal portion 251 of the nut 250 at the proximal end of the nut 250. According to other embodiments, the threaded section may also cover or be located in other portions of the nut 250. The nut 250 further permanently surrounds the stop feature 243 of the piston rod 240, regardless of the set dose and / or the delivered dose.

[0082] The nut 250 has a distal portion 252 that is surrounded by a proximal portion 274 of a clutch member 270 of the dispensing mechanism 230. The nut 250 is pivotally secured to the clutch member 270 and is axially movable relative to the clutch member 270.

[0083] In this embodiment, the nut 250 is engaged with the clutch member 270 by a splined connection between the nut 250 and the clutch member 270. The splined connection illustratively includes longitudinal grooves 254 located on an outer surface of the distal portion 252 of the nut 250 and distributed around the circumference of the nut 250. The grooves 254 are engaged by corresponding longitudinal ridges 271 extending parallel to the longitudinal axis 207 and distributed on an inner surface of the clutch member 270. See FIG. 6.

[0084] According to other embodiments, the pivotally fixed, axially movable connection between the nut 250 and the clutch member 270 may also be achieved by different means, for example by a spline connection between longitudinal ridges on the outer surface of the nut 250 and corresponding longitudinal grooves on the inner surface of the clutch member 270. Additionally or alternatively, the connection may also be mediated by one or more intermediate members.

[0085] The clutch member 270 is fixedly connected at its distal end to the dose setting member 290 by a connection 277 that prevents both relative axial and relative rotational movement between the clutch member 270 and the dose setting member 290. According to other embodiments of the drug delivery device 200, the dose setting member 290 and the clutch member 270 may also be configured as a single component. Alternatively, the connection between the clutch member 270 and the dose setting member 290 may also be mediated by one or more intermediate members.

[0086] At its proximal portion 251, the nut 250 is surrounded by a driver 350. The driver 350 is configured as a hollow, generally cylindrical member. Furthermore, the driver 350 is both axially and rotationally movable relative to the housing 210 during both dose setting and dose delivery. Thus, the driver 350 is threadably engaged with the housing 210.

[0087] At its proximal end, inner housing 180 includes inner sleeve 183 that receives proximal portion 351 of driver 350. Driver 350 includes threads 353 that engage drive threads 186 of inner sleeve 183. In the exemplary embodiment, threads 353 of driver 350 are configured as external threads and drive threads 186 are configured as internal threads. Threads 353 are located on proximal portion 351 of driver 350. According to other embodiments, the threaded connection between driver 350 and housing 210 may also be achieved in other manners, for example, with external threads on housing 210 and internal threads on driver 350.

[0088] The dosing mechanism 230 further comprises a dosing member 330. The dosing member 330 is configured as a hollow, generally cylindrical member. The dosing member encloses both the driver 350 and the clutch member 270. The dosing member 330 constitutes a dose setting sleeve of the drug delivery device 200.

[0089] The driver 350 is located within the proximal portion 331 of the dispensing member 330 and the clutch member 270 is located with its proximal portion 274 within the distal portion 333 of the dispensing member 330 .

[0090] The dispensing member 330 is axially movable and pivotable relative to the housing 210 during both dose setting and dose delivery. The dispensing member is further threadably engaged with the housing 210 such that it is constrained to move on a helical path relative to the housing 210.

[0091] The dispensing member 330 is located between the inner sleeve 183 and the outer wall of the inner housing 180. The dispensing member has a thread 335 that is engaged with the dose thread 185 of the housing 210 (see FIG. 8 ). According to an exemplary embodiment, the thread 335 of the dispensing member 330 is configured as an external thread, and the dose thread 185 is configured as an internal thread located on the inner surface of the outer wall of the inner housing 180. According to other embodiments, the threaded connection between the dispensing member 330 and the housing 210 may also be realized in a different manner. For example, a threaded connection may be provided between the dispensing member 330 and the inner sleeve 183 of the inner housing 180.

[0092] The dispensing member 330 is configured as a dose indicating member and comprises an optical marker 331 on its outer surface. The optical marker 331 forms a helical scale having a pitch corresponding to the pitch of the thread 335 on the outer surface of the dispensing member 330.

[0093] The driver 350 is axially movable and pivotally fixed relative to the dispensing member 330 during both dose setting and dose delivery. According to an exemplary embodiment, this is achieved by a splined connection between the driver 350 and the dispensing member 330.

[0094] The driver 350 comprises radially extending longitudinal splines 360 which engage with corresponding longitudinal grooves 341 provided on the inner surface of the dispensing member 330 (see FIG. 6 ). The splines 360 are located in a distal portion 359 of the driver 350 and the grooves 341 are located in a proximal portion 332 of the dispensing member 330. According to other embodiments, the spline connection between the driver 350 and the dispensing member 330 may also be achieved in a different manner. For example, the driver 350 may comprise grooves which are engaged by corresponding splines of the dispensing member 330.

[0095] The dose selector member 310 is configured as a hollow, generally cylindrical member. The dose selector member constitutes the dose selector sleeve of the drug delivery device 200.

[0096] The dose selector member 310 is axially fixed and pivotally movable relative to the dispensing member 330. The dose selector member 310 is thus constrained to follow the movement of the dispensing member 330 in the axial direction, while the dispensing member 330 is free to pivot relative to the dose selector member 310, which is itself pivotally fixed relative to the housing 210.

[0097] The dispensing member 330 is received in the dose selector member 310. According to the current embodiment, a proximal portion 317 of the dose selector member 310 receives a distal portion 333 of the dispensing member 330. A clutch member 270, whose proximal portion 274 is located in the dispensing member 330, extends axially from the dispensing member 330 by its distal portion 275. Thus, the distal portion 275 of the clutch member 270 extends through an opening 323 in a radially oriented inner wall 322 of the dose selector member 310 (see FIG. 5 ), the inner wall 322 separating the proximal portion 317 from the distal portion 311 of the dose selector member 310.

[0098] FIG. 8 shows a longitudinal section of the dosing mechanism 230 of the drug delivery device 200 through a first cross section before setting a dose delivered by the drug delivery device 200. To set a dose, the dose setting member 290 is gripped by a user and rotated relative to the housing 210. This causes the clutch member 270 to rotate together with the dose setting member 290. Due to the pivotally fixed connection between the clutch member 270 and the nut 250, the nut 250 also rotates together with the dose setting member 290. Since the piston rod 240 is pivotally fixed relative to the housing 210 and is threadably engaged with the nut 250, the rotation of the nut 250 causes the nut 250 to advance axially along the piston rod 240 in the distal direction. When increasing the set dose, the nut 250 advances in the distal direction, and when decreasing the set dose, the nut 250 advances in the proximal direction.

[0099] During dose setting, the dose setting member 290 is pivotally fixed relative to the dispensing member 330. This is achieved by a clutch mechanism 234 that includes a first part 235 acting between the dose setting member 290 and the dispensing member 330.

[0100] A first part 235 of the clutch mechanism 234 is located on the dispensing member 330 and comprises a clutch element 336 (see Figure 7) which, during dose setting, engages a corresponding clutch element 273 located on the clutch member 270. The engagement between these clutch elements 336, 273 prevents relative rotational movement between the dose setting member 290 and the dispensing member 330 while allowing axial movement for disengagement of the first part 235 of the clutch mechanism 234.

[0101] Since the first part 235 of the clutch mechanism 234 is closed during dose setting, the dispensing member 330 rotates together with the dose setting member 270. The threaded engagement between the dispensing member 330 and the housing 210 then advances the dispensing member 330 axially within the housing 210 during dose setting. Increasing the set dose advances the dispensing member 330 in a distal direction and decreasing the set dose advances the dispensing member 330 in a proximal direction.

[0102] Because the dose selector member 310 is axially fixed relative to the dispensing member 330, distal movement of the dispensing member 330 advances the dose selector member 310 axially in the distal direction out of the housing 310, thereby causing the dose setting member 290 to also move in the distal direction, and simultaneously proximal movement of the dispensing member 330 advances the dose selector member 310 axially into the housing 210, thereby causing the dose setting member 290 to also move in the proximal direction.

[0103] Since the dispensing member 330 is pivotally fixed to the driver 350, rotation of the dispensing member 330 also rotates the driver 350 together with the dose setting member 290. The threaded connection between the driver 350 and the housing 210 then causes the driver 350 to move in a distal direction when the set dose is increased and in a proximal direction when the set dose is decreased.

[0104] The first pitch of the threaded connection between the piston rod 240 and the nut 250 and the second pitch of the connection between the driver 350 and the housing 210 are matched to each other such that the nut 250 and the driver 350 advance in essentially the same axial direction upon pivoting movement of the dose setting member 290. The first pitch and the second pitch are smaller than the third pitch of the threaded connection between the dispensing member 330 and the housing 210. This causes the dispensing member 330 to advance a greater axial distance than the nut 250 and the driver 350 upon pivoting movement of the dose setting member 290.

[0105] The device 200 allows the nut 250 and the clutch member 270 to be only rotationally locked and to move freely axially relative to each other. This allows the clutch member 270 and the dose setting member 290 to travel a greater distance axially during dose setting than the nut 250. Similarly, the driver 350 and the dispensing member 330 to be only rotationally locked and to move freely axially relative to each other. This allows the dispensing member 330 to travel a greater distance axially during dose setting than the driver 350.

[0106] 9 shows the dose setting mechanism 232 after a dose has been set. During dose setting, the dosing member 330 has advanced a first distance x in a distal direction while the driver 350 has advanced a second distance y and the nut 250 has advanced a third distance z. The first distance x is greater than the second distance y and the third distance z.

[0107] Due to manufacturing tolerances, the first pitch of the threaded connection between the piston rod 240 and the nut 250 varies between a minimum first pitch and a maximum first pitch among different threaded connections, and the second pitch of the threaded connection between the driver 350 and the housing 210 varies between a minimum second pitch and a maximum second pitch among different threaded connections. According to the drug delivery device 200, the maximum first pitch is equal to or less than the minimum second pitch. This ensures that the second distance y that the driver 350 travels distally is always slightly greater than the third distance z that the nut 250 travels.

[0108] The dose setting member 290, which also acts as an actuation member for effecting injection of the set dose, is axially movable between a distal position and a proximal position relative to the dose selector member 310 and the dispensing member 330. A biasing member 308 configured as a compression spring biases the dose setting member 290 towards the distal position during dose setting.

[0109] To perform the ejection of the set dose, the user of the device 200 pushes the actuation member formed by the dose setting member 290 from a distal position to a proximal portion, which transitions the dosing mechanism 230 from a dose setting state to a dose delivery state. The dosing mechanism 230 of the drug delivery device 200 is configured to allow setting of the dose to be injected when the dose delivery device 200 and the dosing mechanism 230 are in the dose setting state, whereas the dosing mechanism 230 is configured to allow delivery of the set dose when the dose delivery device 200 and the dosing mechanism 230 are in the dose delivery state.

[0110] 10 shows the dosing mechanism 230 after a dose has been set and the dosing mechanism 230 has been transitioned from the dose setting state to the dose delivery state. Moving the dose setting member 290 in a proximal direction also moves the clutch member 270 in a proximal direction, causing the first part 235 of the clutch mechanism 234 to open and disengage the clutch element 273 of the clutch member 270 from the clutch element 336 of the dosing member 330. The dosing member 330 and the driver 350 are therefore free to rotate relative to the dose setting member 290, the clutch member 270 and the nut 250.

[0111] At the same time, proximal movement of the dose setting member 290 relative to the dose selector member 310 closes the second part 236 of the clutch mechanism 234 and pivotally locks the nut 250 relative to the piston rod 240 and the housing 210. The second part 236 of the clutch mechanism 234 acts between the dose selector member 310 and the dose setting member 290 and is further described below in relation to Figures 12 and 13.

[0112] The dose setting member 290 is then pushed further in the proximal direction causing the dose selector member 310 to move linearly back into the housing 210. Thus, the dose selector member 310 pushes the dispensing member 330, which is caused to rotate due to its threaded engagement with the housing 210. The rotation of the dispensing member 330 is transmitted to the driver 350, which therefore also moves in the proximal direction due to its threaded engagement with the housing 210.

[0113] Thus, a mechanical advantage is created where the difference between the pitch of the threaded connection between the dosing member 330 and the housing 210 and the pitch of the threaded connection between the driver 350 and the housing 210 is exerted by the user and which transforms a first axial force acting on the dosing member 330 into a second axial force exerted by the driver 350. According to the dose delivery device 200, the second axial force is greater than the first axial force.

[0114] When moving proximally during dose delivery, the driver 350 pushes the nut 250 axially, thereby advancing the nut 250 proximally. Because the nut 250 is prevented from rotating relative to the piston rod 240 during dose delivery due to its connection to the housing 210 via the clutch member 270, the dose setting member 290 and the dose selector member 310, the threaded connection between the nut 250 and the piston rod 240 axially fixes the nut 250 and the piston rod 240 relative to each other during dose delivery. Thus, by moving the nut 250 axially, the piston rod 240 is also urged to move proximally, thereby advancing the plunger 9 and expelling the drug from the drug compartment 81.

[0115] The housing 250, the dosing member 330 threadably engaged with the housing 250 and pivotably engaged with the driver 350, the driver 350 also threadably engaged with the housing 250, and the nut 250, which is pushed proximally by the driver 350 during dose delivery, form an advancement mechanism of the drug delivery device 200. The advancement mechanism is configured to convert an axial movement of the dosing member 330 into an axial advancement of the piston rod 240 during dose delivery. Thus, the advancement mechanism comprises a gearing mechanism provided by the threaded connections with different pitches between the housing 250 and the dosing member 330 on the one hand and between the housing 250 and the driver 350 on the other hand. The gearing mechanism performs a mechanical advantage that converts a first axial force exerted by the user acting on the actuation member formed by the dose setting member 290 into a second axial force exerted by the piston rod 240 on the plunger 9. This second axial force corresponds to a second axial force exerted by the driver 350 on the nut 250. According to this embodiment, the second axial force is different from the first axial force, i.e., is greater than the first axial force. According to other embodiments, the second axial force may also be less than the first axial force or may be essentially equal to the first axial force.

[0116] Closing the second part 236 of the clutch mechanism 234 upon dose delivery also pivotally locks the dose setting member 290 relative to the housing 210 during dose delivery. This ensures that the dose setting member 290 does not rotate during dose delivery and thus avoids disturbing the user with the rotation of the dose setting member 290 when the user presses the dose setting member 290 to perform dose delivery. The drug delivery device 200 does not comprise any components that are accessible by the user from outside the device 200 and that rotate during dose delivery. This helps ensure safe delivery of the drug during injection.

[0117] 11 shows the dosing mechanism 230 after a dose has been delivered. The nut 250, the driver 350 and the dosing member 330 have returned to their initial positions, while the piston rod 240 has advanced a third distance z in the proximal direction. The piston rod 240 pushes the plunger 9 through the plunger disc 242, which has also been moved a third distance z in the proximal direction.

[0118] FIG. 12 shows the clutch mechanism 234 of the dosing mechanism 230 in a dose setting state, and FIG. 13 shows the clutch mechanism 234 in a dose delivery state.

[0119] 12 , the dose setting member 290 and the clutch member 270 are in their distal positions relative to the dose selector member 310 and the dispensing member 330. The first part 235 of the clutch mechanism 234 is closed, pivotally securing the clutch member 270 to the dispensing member 330.

[0120] The second part 236 of the clutch mechanism 234 is configured to pivotally secure the dose setting member 290 to the dose selector member 310 during dose delivery. The second part 236 comprises a clutch element 294 (see also FIG. 15 ) provided on the dose setting member 290. As can be seen in FIG. 13 , by moving the dose setting member 290 to a proximal position, the clutch element 294 is engaged with a functional feature 312 of the dose selector member 311, thereby pivotally locking the dose setting member 290 to the dose selector member 311. The functional feature 312 is configured as a tooth. The functional feature 312 is provided on an inner surface of the distal part 311 of the dose selector member 310. The functional feature constitutes the clutch element of the dose selector member 310. As can also be seen in FIG. 13, pushing the dose setting member 290 towards a proximal position causes the clutch element 273 of the clutch member 270 to disengage from the clutch element 336 of the dispensing member 330.

[0121] Generally speaking, the clutch mechanism 234 rotationally locks the nut 250 to the dosing member 330 and / or driver 350 during dose setting and rotationally decouples the nut 250 from the dosing member 330 and / or driver 350 during dose delivery. Furthermore, generally speaking, the dosing mechanism 230 is configured to prevent relative rotational movement between the nut 250 and the piston rod 240 and / or housing 210 during dose delivery and to allow rotation of the nut 250 relative to the piston rod 240 and / or housing 210 during dose setting. According to the drug delivery device 200, this is achieved by the clutch mechanism 234.

[0122] The clutch mechanism 234 further pivotally locks the dose setting member 290 to the dispensing member 330 during dose setting and allows relative rotation between the dose setting member 290 and the dispensing member 330 during dose delivery. The clutch mechanism 234 also pivotally locks the dose setting member 290 to the housing 210 during dose delivery and allows relative rotation between the dose setting member 290 and the housing 210 during dose setting.

[0123] According to other embodiments of the drug delivery device 200, the dose setting member 290 may also be permanently pivotally locked to the dosing member 330. For example, such a dose setting member 290 may be configured as a part of the dosing member 330 that is accessible to a user of the device. Such an embodiment of the drug delivery device 200 may then comprise an actuating member that can be pressed by a user to effect a dose delivery and that is separate from the dose setting member 290. The actuating member may then be rotationally movable relative to the dose setting member 290 at least during dose delivery. The nut 250 may then be pivotally decoupled from the dosing member 330 by pushing the actuating member in a proximal direction upon initiation of dose delivery.

[0124] The dosing mechanism 230 of the drug delivery device 200 further comprises a dose defining mechanism 232 acting between two members of the dosing mechanism 230 that are rotationally movable relative to each other during dose setting. The dose defining mechanism 232 defines distinct and / or discrete rotational positions of the dose setting member 290 and the dosing member 330 relative to the housing 210 that correspond to individual settable doses of drug expelled by the dosing mechanism 230. Furthermore, the dose defining mechanism 232 provides auditory and / or tactile feedback to a user of the drug delivery device 200, thereby indicating the rotational positions of the dose setting member 290 and the dosing member 330 that correspond to the settable doses.

[0125] According to an exemplary embodiment of the drug delivery device 200, the dose setting member 290 is configured to perform more than one complete rotation during dose setting. Thus, one discrete rotation position of the dose setting member 290 may correspond to more than one settable dose. The dose setting member 219 then assumes a different axial position, e.g., a discrete axial position, relative to the housing 210 for each individual settable dose. According to another embodiment of the drug delivery device 200, the dose setting member 290 may also be configured to perform less than one complete rotation during dose setting. The discrete rotation positions of the dose setting member 290 defined by the dose defining mechanism 232 then also correspond to distinctly different rotation positions. Generally, due to the distinctly different rotation positions, each individual rotation position corresponds to only a single dose value that can be set by the dose defining mechanism 232. According to the drug delivery device 200, the dose regulation mechanism 232 acts between the dose selector member 310 and the dose setting member 290, as can be seen from Figures 12 and 13. Thus, the dose regulation mechanism 232 is realized by a direct engagement between the dose setting member 290 and the dose selector member 310. According to other embodiments of the dose delivery device according to the present disclosure, the dose regulation mechanism 232 may also act between the dose selector member 310 and the dose setting member 290 via an additional element located between the dose selector member 310 and the dose setting member 290. Such additional element may be, for example, a clutch member 270 and / or a dosing member 330.

[0126] As can also be seen from Fig. 12, the dose setting mechanism 232 comprises at least one element 292 which engages with at least one corresponding functional feature 312, illustratively one of the teeth, when the dose setting member 290 reaches a pivoted position relative to the housing 210 corresponding to a respective dose defined by the functional feature 312. The engagement between the element 292 and the functional feature 312 then provides an auditory and / or tactile feedback to a user of the drug delivery device 200. As can be seen from Fig. 12, the element 292 is provided on the dose setting member 290. In particular, the element 292 is configured as an integral element of the dose setting member 290.

[0127] At least one of the element 292 and the functional feature 312 is configured as a flexible element that is radially deflected upon engagement between the element 292 and the functional feature 312. According to the drug delivery device 200, the element 292 is configured as such a flexible element. Additionally or alternatively, according to other embodiments of the dose regulation mechanism 232, the functional feature 312 may also be configured as a flexible element.

[0128] The functional feature 312 constitutes a dose stop of the drug delivery device 200. By means of said teeth, the drug delivery device 200 comprises several functional features 312 distributed circumferentially around the longitudinal axis 207 to define a number of settable doses. The functional features 312 form a rigid element of the dose defining mechanism 232, which interacts with a flexible element formed by the element 292. The element 292 interacts with the functional feature 312 by riding on the functional feature 312 during dose setting. Thus, the flexible element exemplarily formed by the element 292 bends in the radial direction.

[0129] According to each individual functional feature 312, the drug delivery device 200 comprises at least one element involved in performing the two functions of the dosing mechanism 230. As a component of the clutch mechanism 234, said element constitutes a clutch element serving to pivotally fix the nut 250 and / or the dose setting member 290 to the piston rod 240 and / or the housing 210. As a component of the dose regulation mechanism, said element constitutes a dose stop that defines the rotational position of the dosing member 330 and / or the dose setting member 290 relative to the housing 210. According to other embodiments of the drug delivery device 200, the functional feature 312 may act only as a dose stop and not as a clutch element, or may act only as a clutch element and not as a dose stop. According to the drug delivery device 200, the element performing the two functions is configured as a rigid tooth. Other embodiments may include elements configured differently, such as elastic elements. In particular, the element acting as a dose stop may be configured as an elastic element.

[0130] Furthermore, the dose setting mechanism 232 of the drug delivery device 200 comprises a plurality of elements 292, i.e. four elements 292, distributed circumferentially around the longitudinal axis 207. The relative positions between the individual functional features 312 and the individual elements 292 are selected such that at each rotational position of the dose setting member 290 relative to the housing 210, corresponding to a settable dose, all the elements 292 engage with the respective functional features 312. Other embodiments of the drug delivery device 200 may also comprise other numbers of elements 292, e.g. a single element 292.

[0131] According to the drug delivery device 200, the functional feature 312 may be located on an inner surface of the dose selector member 310 and the element 292 may be located on an outer surface of the dose setting member 290. Furthermore, the element 292 and three further elements 292 are configured as flexible arms, which constitute an integral part of the dose setting member 290 and are provided at the proximal end of the dose setting member 290.

[0132] According to the drug delivery device 200, the functional feature 312 comprises a flat side that engages with a corresponding flat side of the element 292. Additionally, the clutch element 294 also comprises a flat side that engages with a flat side of the functional feature 312. If this is the case for the drug delivery device 200, the flat side of the functional feature 312 and / or the clutch element 294 and / or the element 292 may be angled with respect to a radial plane that includes the longitudinal axis 207 and intersects the flat side of the respective functional feature 312 and / or the clutch element 294 and / or the element 292.

[0133] The functional feature 312 provided on the dose selector member 310 constitutes both a clutch element of the second part 236 of the clutch mechanism 234 and a dose stop of the dose measurer mechanism 232 .

[0134] The dose setting mechanism 232 is configured to inhibit tactile and / or auditory feedback provided to the user during dose setting when the drug delivery device 200 is in a dose delivery state. According to the drug delivery device 200, this is illustratively achieved by preventing relative rotation between the two members providing the dose setting mechanism 232, namely the dose setting member 290 and the dose selector member 310.

[0135] Figure 14 shows a radial cross section through the dose setting mechanism 232 perpendicular to the longitudinal axis 207. Figure 15 shows a proximal perspective view of the dose setting member 290 of the drug delivery device 200, and Figure 16 shows a distal perspective view of the clutch member 270.

[0136] As can be seen from Figure 14, the dose setting mechanism 232 defines an odd number of discrete rotational positions of the dose setting member 290 relative to the housing 210, i.e. 27 rotational positions / settable doses, which correspond to the settable doses. To ensure accurate rotational alignment between the first part 235 and the second part 236 of the clutch mechanism 234, the dose setting member 290 is connected to the clutch member 270 by a connection 277 having a coding feature that allows only a single relative rotational direction between the clutch member 270 and the dose setting member 290.

[0137] The connection 277 includes a non-circular, i.e. rectangular, opening 296 in the dose setting member 290 that receives the non-circular, i.e. rectangular, distal portion 275 of the clutch member 270. In this regard, the coding feature includes a first longitudinal ridge 279 and a second longitudinal ridge 280, such that the longitudinal ridges 279, 280 extend radially from opposite sides of the distal portion 275 of the clutch member 270. The first ridge 279 is received within a corresponding first longitudinal groove 297 located within the opening 296 of the dose setting member 290, and the second ridge 280 is received within a corresponding second longitudinal groove 298 of the dose setting member 290. The first ridge 279 and the first groove 297 have different dimensions, in particular widths, that differ from the respective dimensions, in particular widths, of the second ridge 280 and the second groove 298. According to other embodiments of the drug delivery device 200, the coding feature of the connection 277 may also be realised in a different manner, for example by means of a ridge provided on the dose setting member 290 and a corresponding groove provided in the clutch member 270.

[0138] To permanently and non-releasably couple the dose setting member 290 to the clutch member 270 during assembly of the drug delivery device 200, the clutch member 270 is locked to the dose setting member 290 by a snap-fit ​​connection 277. For example, as can be seen from Figs. 15 and 16, this snap-fit ​​connection 277 comprises two flexible snap hooks 278 located on opposite sides of the distal portion 275 of the clutch member 270. When the distal portion 275 is inserted into an opening 296 of the dose setting member 290, the snap hooks 278 engage with corresponding recesses 295 provided in the sides of the opening 296. According to other embodiments, the non-releasable connection 277 may also be provided in a different manner, for example by at least one snap hook located on the dose setting member 290 and at least one corresponding recess located on the clutch member 270.

[0139] As will be explained in more detail below, axial positions of the dispensing member 330 corresponding to the minimum and maximum settable doses are defined by the interaction between the dispensing member 330 and the inner housing 180. Thus, the connection between the dose selector member 310 and the inner housing 180 is configured such that these axial positions correspond to the settable doses defined by the dose defining mechanism 232.

[0140] According to the drug delivery device 200, such a connection, shown in Fig. 14, is achieved by constraining the relative rotational direction between the dose selector member 310 and the inner housing 180 to a single orientation. The connection is established by a first longitudinal ridge 315 provided on the outer surface of the dose selector member 310 and received in a corresponding first longitudinal groove 187 provided on the inner surface of the inner housing 180. The first longitudinal ridge 315 has a dimension, in particular a width, different from the corresponding dimension, in particular width, of at least one, in particular three further longitudinal ridges 316 distributed over the remaining outer surface of the dose selector member 310. The further longitudinal ridges 316 engage with corresponding further longitudinal grooves 188 distributed over the remaining inner surface of the inner housing 180 and having a corresponding width different from the width of the first longitudinal groove 187.

[0141] Generally, the first longitudinal ridge 315 and the first longitudinal groove 187 form a first longitudinal spline connection, and the further longitudinal ridge 316 and the further longitudinal groove 188 form at least a second longitudinal spline connection, the first longitudinal spline connection having different dimensions, in particular a lateral width, than the second longitudinal spline connection. According to other embodiments, the connection between the dose selector member 310 and the inner housing 180 may also be achieved in a different manner, for example by a spline connection having a groove located on the dose selector member 310 and a ridge located on the inner housing 180.

[0142] 17 shows a perspective view of the proximal side of the clutch member 270 of the drug delivery device 200. On the inner surface of its proximal portion 274, the clutch member 270 has a longitudinal ridge 271 that engages with a longitudinal groove 254 of the nut 250 to pivotally lock the clutch member 270 to the nut 250 while simultaneously allowing relative axial movement. Generally speaking, the longitudinal ridge 271 and the corresponding longitudinal groove 254 form a splined connection between the clutch member 270 and the nut 250. According to other embodiments, the pivotally fixed and axially movable connection between the clutch member 270 and the nut 250 may also be achieved by other means, for example by a longitudinal ridge provided on the nut 250 and a corresponding groove provided on the clutch member 270.

[0143] 18 shows a longitudinal section through the dosing member 330 and the dose setting member 310 of the drug delivery device 200. The drug delivery device 200 comprises a friction reduction mechanism acting between the dosing member 330 and the dose selector member 310. The friction reduction mechanism is configured to reduce friction during relative rotational movement between the dosing member 330 and the dose selector member 310.

[0144] The friction reduction mechanism comprises a ball bearing 370 provided between a distal surface 346 of the dosing member 330 and a contact surface 314 of the dose selector member 310. Thus, the contact surface 314 is provided by a proximal front surface of the radially inner wall 322 of the dose selector member 310. The distal surface 346 is generally the distally facing surface of the dosing member 330. According to the drug delivery device 200, the distal surface 346 is the distal end surface of the dosing member 330. According to other embodiments, the distal surface 346 may also be located at a different position of the dosing member 330.

[0145] When the dose is increased during dose setting, a distally directed axial force is transmitted from the dosing member 330 via the ball bearing 370 to the dose selector member 310. When the dose selector member 310 is pushed proximally during injection, a proximally directed axial force is transmitted from the dose selector member 310 via the ball bearing 370 to the dosing member 330.

[0146] The ball bearing 370 comprises a number of balls 375 sandwiched between a distal disc 371 that contacts the contact surface 314 of the dose selector member 310 and a proximal disc 372 that contacts the distal surface 346 of the dispensing member 330. Furthermore, the ball bearing 370 comprises a holder 372 that is sandwiched between the distal disc 371 and the proximal disc 372. The holder 372 radially surrounds the balls 375 and holds them in place.

[0147] The dose selector member 310 has a connection to the dispensing member 330 that is configured to constrain movement between the dose selector member 310 and the dispensing member 330 in the axial direction and to allow relative rotation between the dose selector member 310 and the dispensing member 330. Distal movement of the dose selector member 310 relative to the dispensing member 330 is prevented by a snap-fit ​​connection. The snap-fit ​​connection includes a circumferential annular ridge 344 on the outer surface of the dispensing member 330 and at least one, i.e. four, flexible members 319 formed on the dose selector member 310. Upon proximal movement of the dose selector member 310 over the dispensing member 330 during assembly, the flexible member 319 snaps over the annular ridge 344 and engages with a proximal front face of the annular ridge 344. According to other embodiments, distal movement of the dose selector member 310 may also be achieved by a different connection, for example by a flexible member of the dosing member 330 engaging an annular ridge of the dose selector member 310. Proximal movement of the dose selector member 310 relative to the dosing member 330 is prevented by a contact surface 314 of the dose selector member 310 resting against a distal end face 346 of the dosing member 330 via a ball bearing 370.

[0148] According to other embodiments of the drug delivery device 200, the bearing element 370 may also be configured in other manners. For example, the bearing element 370 may also be configured as a disc bearing, such as a single annular disc made from a low friction material such as PTFE.

[0149] 19 shows a perspective view of a connection 354 between the nut 250 and the driver 350 of the drug delivery device 200. The connection 354 is configured to axially constrain the driver 350 relative to the nut 250 and to allow relative rotational movement between the nut 250 and the driver 350.

[0150] Connection 354 is formed at the distal end of driver 350 and includes two flexible arms 356 that project radially inwardly to engage annular detents 255 between proximal and distal portions 251, 252 of nut 250. When driver 350 is moved distally relative to nut 250, flexible arms 356 abut against distal sides of annular detents 255. A clearance is provided between the distal sides and flexible arms 356 to allow nut 250 and driver 350 to advance distally different distances during dose setting.

[0151] The drug delivery device 200 comprises a further friction reducing mechanism configured to reduce friction between the nut 250 and the driver 350 during their relative rotational movement with respect to one another during dose delivery. The further friction reducing mechanism includes a bearing element 380 positioned between the driver 350 and the nut 250 during dose delivery.

[0152] The bearing element 380 is located between a proximal front face 358 of the driver 350 and a proximally located protrusion 253 of the nut 250. The proximal protrusion 253 defines a rim extending radially from the nut 250. When rotated into the inner sleeve 183 of the inner housing 180 during dose delivery, the proximal front face 358 of the driver 350 presses against the protrusion 253 via the further bearing element 380, thus also pressing the nut 250 in the proximal direction.

[0153] The bearing element 380 is configured as a bearing disk made from a low friction material such as PTFE. According to other embodiments, the bearing element 380 may also be configured as a different type of bearing, for example a ball bearing.

[0154] According to the drug delivery device 200, the driver 350 is generally configured to advance the nut 250 axially during dose delivery by indirectly transmitting axial force to the nut 250, i.e., by transmitting axial force to the nut 250 via one or more intermediate members, i.e., bearing elements 380.

[0155] The piston rod 240 is pivotally fixed relative to the housing 210 at least during dose delivery, and the nut 350 and the piston rod 240 are pivotally fixed relative to each other during dose delivery, such that the threaded connection 241, 256 between the nut 250 and the piston rod 240 axially locks the nut 250 to the piston rod 240 during dose delivery. Thus, the nut 250 and the piston rod 240 are configured to move axially together during dose delivery as if they were a single member.

[0156] The nut 250 is configured to rotate relative to the piston rod 240 during dose setting, such that the piston rod 240 is also pivotally locked relative to the housing 210 during dose setting, and the nut 250 is configured to rotate relative to the housing 210 during dose setting, such that due to the threaded connection 241, 256 between the nut 250 and the piston rod 240, rotation of the nut 250 advances the nut 250 axially relative to the piston rod 240 during dose setting. The axial advancement of the nut 250 relative to the piston rod 240 and / or the housing 210 then also defines the axial advancement of the piston rod 240 relative to the housing 210 during dose delivery.

[0157] 20 shows a perspective view of the dosing member 330 of the drug delivery device 200. The dosing member 330 comprises a maximum dose stop 337 configured to engage with the inner housing 180 upon setting of a maximum dose. Thus, engagement of the maximum dose stop 337 with the inner housing 180 limits further axial movement of the dosing member 330 in the distal direction and defines an axial and rotational position of the dosing member 330 corresponding to the maximum dose settable by the dosing mechanism 230.

[0158] As can be seen in FIG. 21 , which shows the inner housing 180 in a longitudinal cross section through the longitudinal axis 207, the inner housing 180 comprises at least one maximum stop feature 190, i.e., four maximum stop features 190. The maximum stop features 190 are formed as an integral part of the inner housing 180. Each maximum stop feature comprises a flexible hook 191 that projects radially inwardly into the housing cavity 189 of the inner housing 180 that receives the dispensing member 330. Each flexible hook 191 is oriented perpendicular to the longitudinal axis 207 and comprises a limiting surface 192 facing in a proximal direction.

[0159] When the dispensing member 330 is inserted into the housing cavity 189, the flexible hook 191 snaps over the maximum dose stop 337 and thereafter limits the distal axial movement of the dispensing member 330. When the maximum dose is set, a distal stop surface 338 of the maximum dose stop 337 abuts the limiting surface 192 of the maximum stop feature 190. The distal stop surface 338 is configured as a side surface of the maximum dose stop 337 and is oriented perpendicular to the longitudinal axis 207.

[0160] As can be seen in Fig. 20, the dispensing member 330 also comprises a zero dose stop 340 which defines a rotational and axial position of the dispensing member 330 corresponding to a zero dose or no set dose. The zero dose stop 340 is located at the proximal end of the dispensing member 330. The zero dose stop is configured as a limiting surface which is oriented parallel to the longitudinal axis 207. The limiting surface forms a side of a notch in the proximal end of the dispensing member 330.

[0161] Upon reaching the zero dose position, the zero dose stop 340 engages with a zero stop feature 196 of the inner housing 180, shown in FIG. 21. The zero stop feature 196 is located at a proximal end of the housing cavity 189. Similar to the zero dose stop 340, the zero stop feature 196 is also configured as a limiting surface 197 that is oriented parallel to the longitudinal axis 207. Additionally, the limiting surface 197 of the zero stop feature 196 is oriented parallel to the limiting surface of the zero dose stop 340.

[0162] The zero dose stop 340 engages the zero stop feature 196 in a contact plane that is angled with respect to a radial plane that is oriented perpendicular to the longitudinal axis 207. According to this embodiment, the contact plane is oriented perpendicular to the radial plane and parallel to the limiting surface 197 provided by the zero dose stop 340 and the zero stop feature 196. Thus, the limiting surface 197 of the zero stop feature 196 provided on the housing of the device 200 coincides with the contact plane.

[0163] FIG. 22 shows a perspective view of the inner housing 180 with the dispensing member 330 in a zero dose position, and FIG. 23 shows a perspective view of the inner housing 180 with the dispensing member 330 in a maximum dose position.

[0164] The dispensing member 330 is configured to perform two complete rotations about the longitudinal axis 207 when moving from the zero dose position to the maximum dose position. In the zero dose position, a minimum dose marker indicating a set dose of 0.0 is visible in the window 188a of the inner housing 180, and in the maximum dose position, a maximum dose marker indicating a set dose of 5.4 is visible in the window 188a.

[0165] According to other embodiments of the drug delivery device 200, the dosing member 330 may be configured to perform less than or more than two full rotations about the longitudinal axis 207 when moving from the zero dose position to the maximum dose position. In particular, the drug delivery device 200 may be configured to perform a non-integer number of rotations that deviate from one full rotation or an integer multiple of one full rotation. Similarly, the maximum dose marker may indicate any other dose that deviates from a set dose of 5.4, for example a set dose of 1.8 or 3.6.

[0166] The inwardly projecting maximum stop feature 190 of the inner housing 180 is located inside the longitudinal detents 320 of the dose selector member 310. This allows the limiting surface 192 to engage with the stop surface 338 of the dispensing member 330, except for the dose selector member 310 which surrounds the dispensing member 330 at its distal portion 333.

[0167] The inner housing 180 is locked both axially and rotationally with respect to the outer housing 211. As can be seen in Figures 22 and 23, the inner housing 180 comprises protrusions 194 that are distributed circumferentially around the outer surface of the distal portion 182 of the inner housing 180. Furthermore, the inner housing 180 comprises a radial protrusion 195 located on the outer surface of the proximal portion 181 of the inner housing 180. According to the embodiment shown in Figures 22 and 23, two radial protrusions 195 are arranged next to each other parallel to the longitudinal axis 207. Both of the two protrusions 195 are arranged in the same circumferential position on the outer surface of the inner housing 180.

[0168] 24, which shows a longitudinal cross-section through the outer housing 211 of the drug delivery device 200, the outer housing 211 includes a circumferential groove 218 on its inner surface located in a distal portion of the outer housing 211. Additionally, the outer housing 211 includes a detent 216 in a proximal portion of its inner surface.

[0169] FIG. 25 shows a longitudinal cross section of the inner housing 180 mounted in the outer housing 211 of the drug delivery device 200. The protrusions 194 in the distal portion 182 of the inner housing 180 are configured to prevent axial movement of the inner housing 180 relative to the outer housing 211 in the distal direction. The protrusions snap into the circumferential groove 218 when the inner housing 180 is mounted inside the outer housing 211 by inserting the inner housing 180 into the outer housing 211 from its distal end. When the inner housing 180 is pushed distally after being fully inserted, the protrusions 194 engage the distal end face of the circumferential groove 218, thereby preventing axial movement. In the proximal direction, the inner housing 180 abuts against a step in the inner surface of the outer housing 211, which limits the proximal movement of the inner housing.

[0170] According to other embodiments of the drug delivery device 200, axial movement of the inner housing 180 relative to the other housing 211 may also be prevented by other means. For example, the outer housing 211 may comprise a flexible element that engages with a groove positioned on the outer surface of the inner housing 180.

[0171] Radial protrusions 195 in the proximal portion of the inner housing 180 are configured to prevent pivotal movement of the inner housing 180 relative to the outer housing 211. The protrusions engage with detents 216 in the proximal portion of the inner surface of the outer housing 211. This is further illustrated in FIG. 26, which shows a radial cross section through the outer housing 211 and the inner housing 180 of the drug delivery device 200 through line AA shown in FIG. 25. According to other embodiments of the drug delivery device 200, radial movement of the inner housing 180 relative to the other housing 211 may also be prevented by other means. For example, the outer housing 211 may include protrusions that engage with detents located on the outer surface of the inner housing 180.

[0172] Upon assembly of the drug delivery device 200, the dose selector member 310 and the dosing member 330 are first assembled to each other and inserted into the inner housing 180. Only afterwards is the inner housing 180 inserted into the outer housing 211. After being inserted into the outer housing 211, the flexible hook 191 rests against the inner surface of the outer housing 211, thus preventing the flexible hook 191 from bending outward. This prevents the hook 191 from disengaging from the maximum dose stop 337 upon setting of the maximum dose.

[0173] In accordance with all drug delivery devices according to the present disclosure, the design of the respective maximum dose stop 337 and zero dose stop 340 is generally independent of the design of the rest of the device, in particular the details of the pivotable coupling between the respective dose setting member and the respective dose sleeve, the respective clutch mechanisms, the dose regulation mechanisms, the reset mechanisms, etc.

[0174] The drug delivery device 200 is configured to deliver multiple individual doses from a cartridge 8 attached to the device 200 via a cartridge holder 412. Furthermore, the drug delivery device 200 is configured as a reusable drug delivery device, allowing a user to replace an empty cartridge 8 with a new cartridge 8 after the last dose has been delivered from a given cartridge 8.

[0175] Thus, the reset mechanism 100, shown in an exploded partial view in FIG. 27, enables the piston rod 240 to move back into the housing 210 after the last dose has been delivered and the cartridge holder 412 has disengaged from the housing 210.

[0176] The reset element 110 of the reset mechanism 100, which guides the piston rod 240 in the non-circular opening 114, is mounted in a housing 210, i.e., an outer housing 211. The connection between the reset element 110 and the housing 210 is achieved by a coupling part 130, which is fixed with respect to the housing 210 both rotationally and axially. The coupling part 130 is configured as an insert that is received in the housing 210, i.e., in the outer housing 211.

[0177] According to the present disclosure, the housing 210 comprises all members that are rotationally and axially permanently fixed to the outer housing 211 during the intended use of the drug delivery device 200. Thus, the coupling portion 130 can also be considered as part of the housing 210. According to other embodiments of the drug delivery device 200, the coupling portion 130 may be configured as an integral part of the housing 210.

[0178] A biasing element 150, configured as a compression spring, is mounted between the coupling portion 130 and the reset element 110, and thus between the housing 210 and the reset element 110. The biasing element 150 biases the reset element 110 in a proximal direction toward a proximal position relative to the housing 210 and the coupling portion 130.

[0179] 28 shows a longitudinal section through the reset mechanism 100 of the drug delivery device 200 with the reset element 110 in a proximal position. In this configuration, the reset element 110 is rotationally movable relative to the housing 210. The reset element 110 includes a gripping zone 111 at its proximal end, which can be gripped by a user of the device 200 to rotate the reset element 110. Within the gripping zone 111, the reset element 110 has a rough outer surface, such as a wavy outer surface.

[0180] Due to the pivotally fixed connection between the reset element 110 and the piston rod 240, when the user rotates the reset element 110, the piston rod 240 is forced to rotate with the reset element 110. The engagement between the threads 241 of the piston rod 240 and the threads 256 of the nut 250 then forces the piston rod 240 to proceed distally back into the housing 210 upon rotation of the reset element 110 in the reset direction. In this manner, the reset element 110 is configured to move the piston rod 240 back into the housing 210 upon rotation by the user.

[0181] Generally, the piston rod 240 is threadably engaged with a member of the dose setting mechanism 230, i.e., the nut 250, and the reset element 110 rotates relative to this member during resetting of the piston rod 240. When this is illustratively the case for the drug delivery device 200, said member may be rotatably and / or axially fixed relative to the housing 210 of the device 200, and the reset element 110 may be configured to be rotated relative to the housing 210 upon resetting of the piston rod 240.

[0182] Moreover, the piston rod 250 is generally pivotally fixed to the reset element 110 and axially movable relative to the reset element 110, at least during the reset operation. According to the drug delivery device 200, the piston rod 250 is pivotally permanently fixed to the reset element 110. Moreover, the piston rod is axially permanently movable relative to the reset element 110.

[0183] After the cartridge holder 412 is disengaged from the housing 210, the piston rod 240 is accessible to a user of the device 200. The connection 354, which axially restrains the driver 350 relative to the nut 250, serves to prevent undesired movement of the piston rod 240, which may be caused by the piston rod 240 being pushed or pulled directly by the user without the reset element 110 simultaneously rotating.

[0184] For example, if a user sets a dose while the cartridge holder 412 is removed from the housing 210, the nut 250 and the driver 350 will both move in a distal direction. Without the connection 354, the nut 250 will not be prevented from moving proximally again if the user subsequently pulls on the piston rod 240, allowing the user to withdraw the piston rod 240 from the housing 210. This can create the impression that the device 200 is broken.

[0185] The connection 354 prevents the piston rod 240 from being pulled out of the housing 210 by the user without the piston rod 240 simultaneously rotating. That is, axial movement of the piston rod 240 without rotation requires the nut 250 to move axially. Due to the connection 354 between the nut 250 and the driver 350 and due to the threaded connection 352 between the driver 350 and the inner housing 180, the driver 350 also needs to move axially and rotate relative to the housing 210. However, due to gearing or mechanical advantages caused by the different pitches of the threaded connection 352 between the driver 350 and the inner housing 180 and of the threaded connection 334 between the dispensing member 330 and the inner housing 180, the force that the user is typically able to exert by pulling or pushing the piston rod 240 is not large enough to overcome the resistance required to cause rotation of the dispensing member 330, the clutch member 270 and the dose setting member 290 by directly forcing the driver 350 to rotate. Thus, when the dose setting member 290 is not actuated, the driver 350, and via the connection 354 also the nut 250, are essentially rotationally and axially locked.

[0186] 29 shows a distal perspective view of reset element 110, FIG. 30 shows a proximal perspective view of reset element 110, and FIG. 31 shows a proximal perspective view of coupling portion 130 of reset mechanism 110. As shown in FIG.

[0187] As can be seen in Fig. 28, a distal portion of the reset element 110 is received within the coupling portion 130. In the proximal position shown in Fig. 28, further proximal movement of the reset element 110 under the action of the biasing member 150 within the coupling portion 130 is prevented by the reset element 110 engaging with the coupling portion 130 such that a radial stop 119 located at a distal end of the reset element 110 engages a corresponding stop feature 140 on an inner surface of the coupling portion 130. According to other embodiments, further proximal movement of the reset element 110 may also be prevented in other manners.

[0188] As can also be seen in FIG. 28 , the coupling portion 130 is axially locked to the housing 210 by an annular notch 136 located on the outer surface of the coupling portion 130, which is received within a corresponding collar 213 on the inner surface of the outer housing 211. The notch 136 is constrained in a distal direction by a locking structure 137 that protrudes radially from the outer surface of the coupling portion 130. When the coupling portion 130 is inserted distally into the outer housing 211, the locking structure 137 flexes radially inward and snaps onto the annular collar 213 of the outer housing 211. In this manner, the coupling portion 130 is axially fixed to the housing 210 by a snap-fit ​​connection. According to other embodiments, axial movement between the coupling portion 130 and the housing 210 may also be prevented using other means, for example by a notch located on the housing 210 and a collar or protrusion located on the coupling portion 130.

[0189] To pivotally lock the coupling part 130 relative to the housing 210, the coupling part 130 comprises a protrusion 138 located in the notch 136. The protrusion 138 engages with a corresponding detent 214 in the annular collar 213. These detents 214 are shown, among others, in FIG. 24. According to other embodiments, the pivoting between the coupling part 130 and the housing 210 may also be prevented by other means, for example by a protrusion provided on the housing 210 and a corresponding detent provided on the coupling part 130.

[0190] The locking structure 137 of the coupling portion 130 comprises two portions separated by a longitudinal slot 139. This allows those portions of the locking structure 137 to flex radially inward when the coupling portion 130 is mounted to the outer housing 211. After the coupling portion 130 is mounted and the inner housing 180 is mounted to the outer housing 211, those portions of the locking structure 137 are prevented from flexing inward by their engagement with the inner housing 180. When assembling the device 200, the coupling portion 130 and the reset element 110 are first snap-fitted into the outer housing 211 and only then is the inner housing 180 inserted into the outer housing 211.

[0191] Figure 32 shows a perspective view of the coupling portion 130 and the inner housing 180. The inner housing 180 has on its front surface two longitudinally protruding tappets 184, which are also visible, for example, in Figure 23. The tappets 184 are received in the longitudinal slots 139, thereby preventing said portion of the locking structure 137 from bending radially inward.

[0192] 33 shows a longitudinal section through the reset mechanism 100, with the dispensing unit 410 attached to the drug delivery device 200. When attaching the dispensing unit 410, the internal threads of the connecting means 414 of the dispensing unit 410 are screwed into the external threads of the connecting means 510 of the outer housing 211 until the distal end of the cartridge holder 412 rests against a step formed on the outer surface of the outer housing 211.

[0193] During loading of the dispensing unit 410, the reset element 110 is moved distally to its distal position such that the reset element 110 is pivotally locked relative to the housing 210. When in its distal position, the engagement features 120 of the reset element 110 engage with corresponding engagement features 135 of the coupling portion 130, thereby pivotally locking the reset element 110 relative to the coupling portion 130 and the housing 210.

[0194] The engagement feature 120 of the reset element 110 is configured as distally facing teeth. The engagement feature 135 of the coupling portion 130 is located at a coupling site formed by a front surface of the coupling portion 130. The engagement feature 135 is configured as proximally facing teeth that match the distally facing teeth of the engagement feature 120 of the reset element 110.

[0195] In the embodiment shown in Figures 27-33, the engagement features 120, 135 are configured as symmetrical teeth having circumferential flanks with the same slope. According to other embodiments, the teeth of the engagement features 120, 135 may also be configured as asymmetrical teeth. For example, the asymmetrical teeth may have circumferential flanks with different slopes. Thus, one side of each tooth may be oriented, for example, parallel to the longitudinal axis 207, and each other side may be angled relative to the longitudinal axis 207. Such asymmetrical teeth may provide, for example, a sawtooth profile.

[0196] With asymmetric engagement features 120, 135, the sides of each engagement feature 120, 135 having a steeper slope than the other sides may be configured to press against each other when the reset element 110 is rotated circumferentially, thereby screwing the piston rod 240 back into the housing 210. This effectively prevents back-rotation of the piston rod 240 relative to the nut 250 during dose delivery or when the dose setting member 290 and nut 250 are turned too far after the threads 256 of the nut 250 engage the stop feature 243 of the piston rod 240 following a dose increase during dose setting.

[0197] 33, upon mounting of the dispensing unit 410 to the housing 210, the cartridge holder 412 of the dispensing unit 410 directly engages the reset element 110 to push the reset element 110 in a distal direction. Thus, the proximal-facing contact structure 117 of the reset element 110 rests against the distal-facing contact feature 450 of the cartridge holder 412. The proximal-facing contact structure 117 is illustratively configured as a proximal circumferential edge of the reset member 110. The distal-facing contact feature 450 is illustratively provided as a distal-facing annular surface located on an inwardly protruding step of the cartridge holder 412.

[0198] The proximal position of the reset element 110 is the reset position of the reset element 110, and the distal position of the reset element 110 is the locked position of the reset element 110. The locking distance between the reset position and the locked position may be, for example, less than 2 mm, 1.5 mm, 1.25 mm, 1.1 mm, or 1 mm, and / or more than 0.5 mm, 0.7 mm, or 0.8 mm. This distance may be, for example, 0.8 mm, 0.9 mm, 1.0 mm, or 1.1 mm.

[0199] Due to the cartridge holder 412 being mounted to the housing 210, the cartridge 8 does not contact the reset element 110. Thus, the reset element 110 is moved distally only by contact with the cartridge holder 412. The distal end of the cartridge 8 is received inside the cartridge cavity 115 of the reset element 110, which is accessible from a proximal side of the reset element 110.

[0200] The direct engagement between the cartridge holder 412 and the reset element 110 allows the engagement features 120, 135 to be constructed with tighter axial tolerances and smaller axial heights compared to the engagement between the cartridge 8 and the reset element 110. Typically, individual cartridges 8 are made from glass and have greater variation in longitudinal extension than individual cartridge holders 412, which are typically made from a plastic material. Thus, the engagement features 120, 135 need to have a relatively large axial height to provide a secure lock for rotation between the reset element 110 and the coupling portion 130, regardless of possible variations in the length of individual cartridges 8 due to manufacturing tolerances.

[0201] When fully retracted into the housing 210, the plunger disk 242 of the piston rod 240 is located in the receiving area 112 of the reset element 110. The receiving area 112 is configured as a further cavity that is accessible from the proximal side of the reset element 110. Furthermore, the receiving area 112 is located in the cartridge cavity 115 and is accessible from its distal end. In its fully retracted position, the plunger disk 242 of the piston rod 240 rests in an inner surface 113 of the receiving area 112. This inner surface 113 forms the distal end face of the receiving area 112 and surrounds an opening 114 of the reset element 110 that guides the piston rod 240.

[0202] FIG. 34 shows a longitudinal section through the proximal end of a cartridge holder 412 attachable to the drug delivery device 200, with a cartridge 8 inserted into the cartridge holder 412. FIG. 35 shows a perspective distal view of a radial section through the proximal part of the cartridge holder 412 along line BB in FIG. 34. Inside the cartridge holder 412, the cartridge 8 is pressed against a stop 408 by a biasing element 406. The biasing element 406 engages with a distal surface 83 of an annular rim 82 of the cartridge 8. Thus, the biasing element engages with a radially outer end of the distal surface 83. The biasing element 406 is configured as a flexible member that snaps onto the annular rim 82 when the cartridge 8 is inserted into the cartridge holder 412. The biasing element 406 is configured as an integral part of the cartridge holder 412. The biasing element 406 is formed as a notch disposed in the outer wall of the cartridge holder 412 .

[0203] The outer wall of the cartridge holder 412 encloses a cartridge cavity 413 that is configured to receive the cartridge 8. Both the biasing element 406 and the connector 404 project radially into the cartridge cavity 413. The cartridge cavity 413 has a longitudinal extension that is greater than the longitudinal extension of the cartridge 8. This prevents a user of the dispensing unit 410 from being able to touch or grasp the cartridge 8 and remove it from the cartridge holder 412.

[0204] 34, the cartridge holder 412 includes both a biasing element 406 and a connector 404 that are configured as separate elements of the cartridge holder 412. The biasing element 406 and the connector 404 are located on opposite sides of the cartridge holder 412 with respect to the longitudinal axis 207. Furthermore, both the biasing element 406 and the connector 404 are located at the same longitudinal position.

[0205] Thus, the biasing element 406 is configured to bias, in particular permanently bias, the cartridge 8 in the proximal direction towards the stop 408. The cartridge 8 is thus clamped between the stop 408 and the biasing element 406, so that both the stop 408 and the biasing element 406 rest simultaneously against the cartridge 8. The biasing element 406 prevents movement of the cartridge 8 within the cartridge holder 412. For example, the biasing element 406 biases the cartridge 8 in the proximal direction relative to the hollow cannula 6 when the needle 4 is loaded into the cartridge holder 412.

[0206] The connector 404 generally constitutes a locking element that prevents removal of the cartridge 8 after it has been inserted into the cartridge holder 412. Thus, removal is prevented by a contact surface 405 of the connector 404. The contact surface 405 is configured to engage with the cartridge 8 to prevent removal of the cartridge 8 from the cartridge holder 412. Thus, the contact surface 405 acts as a blocking surface that prevents removal of the cartridge 8 from the cartridge holder 412. According to the embodiment shown in FIG. 34, the contact surface 405 is provided by a proximal surface of the connector 404. The contact surface 405 is oriented in the proximal direction. Furthermore, the contact surface is angled with respect to the longitudinal axis 207. The contact surface may be generally oriented perpendicular to the longitudinal axis 207, in particular, perpendicular to the longitudinal axis 207.

[0207] The contact surface 405 engages a corresponding opposing surface of the cartridge 8. The opposing surface of the cartridge 8 is a distally-facing surface that is angled with respect to the longitudinal axis 207. The opposing surface may also be oriented generally perpendicular to the longitudinal axis 207, and may particularly be oriented perpendicular to the longitudinal axis 207. The opposing surface is illustratively provided by a distal surface 83 of annular rim 82 of the cartridge 8.

[0208] The connector 404 is configured to be biased towards the longitudinal axis 207 when the cartridge 8 engages the connector 404 in response to an attempted removal of the cartridge 8 from the cartridge holder 412. This further prevents the cartridge 8 from being removed from the cartridge holder 412 by locking the cartridge 8 inside the cartridge holder 412.

[0209] According to the cartridge holder 412, the contact surface 405 has a larger angle with the longitudinal axis 207 than the opposing surface 83. Upon contacting the opposing surface 83 of the cartridge 8 in response to distal movement of the cartridge 8, the connector 404 flexes to orient its contact surface 405 parallel to the opposing surface 83. This causes the connector 404 to deflect radially toward the longitudinal axis 207 and the cartridge 8 when attempting to remove the cartridge 8 from the cartridge holder 412.

[0210] When fully inserted into the cartridge holder 412, the cartridge 8 is positioned outward from the contact surface 405. The cartridge 8 does not thereafter contact the contact surface 405. The action of the biasing element 406 biases the cartridge 8 towards its fully inserted position.

[0211] The clamped end of the connector 404 is connected to the body of the cartridge holder 412, and the free end of the connector 404 is configured separately from the body of the cartridge holder 412. According to the connector 404, the free end is located at the proximal end of the connector 404 and the clamped end is located at the distal end of the connector 404. The connector 404 is configured as a flexible member. Thus, the free end of the connector 404 can be deflected radially. When the cartridge 8 is inserted into the cartridge holder 412, the cartridge 8 first deflects the connector 404 radially outward from the longitudinal axis 207. When the cartridge 8 moves further proximally, the connector 404 then snaps onto the cartridge 8, i.e. onto the annular rim 82 of the cartridge 8.

[0212] Similarly, the clamped end of the biasing element 406 is connected to the body of the cartridge holder 412, and the free end of the biasing element 406 is configured separately from the body of the cartridge holder 412. According to the biasing element 406, the free end is located at the proximal end of the biasing element 406, and the clamped end is located at the distal end of the biasing element 406. The biasing element 406 is configured as a flexible member. Thus, the free end of the biasing element 406 can be deflected radially. When the cartridge 8 is inserted into the cartridge holder 412, the cartridge 8 first deflects the biasing element 406 radially outward from the longitudinal axis 207. When the cartridge 8 moves further in the proximal direction, the biasing element 406 then snaps onto the cartridge 8, i.e., onto the annular rim 82 of the cartridge 8.

[0213] According to the cartridge holder 412, a contact surface 407 of the biasing element 406 is configured to rest on the cartridge 8 and exert a biasing force in a proximal direction. The contact surface 407 has an angle with the longitudinal axis 207 that is smaller than the angle that the contact surface 405 of the connector 404 makes with the longitudinal axis 207.

[0214] The biasing element 406 is configured to flex radially outwardly from the longitudinal axis 207 and the cartridge 8 in response to an attempted removal of the cartridge 8 from the cartridge holder 412. With the cartridge holder 412, the contact surface 407 of the biasing element 406 has a larger angle with the longitudinal axis 207 than the opposing surface 83 of the cartridge 8.

[0215] The cartridge holder 412 serves two functions: First, it prevents a user from removing the cartridge 8 from the cartridge holder 412 without the use of a tool. Second, it prevents the cartridge 8 from moving axially when a user attaches the needle 4 to the needle connector 402.

[0216] The first function is achieved by the connector 404 having a secure snap-fit ​​after insertion of the cartridge 8. This is illustratively achieved by the connector 404 having some clearance relative to the distal surface 83 of the cartridge 8 after insertion. The distance between the stop 408 and the connector 404 is adapted to accommodate various thicknesses of the annular rim 82 of the cartridge 8. This distance is therefore adapted for various positions of the surface 83 from the stop 408. In general, the connector 404 is spaced from the surface 83 at least for cartridges 8 having an annular rim 8 that is axially shorter than the maximum thickness of the cartridge 8 that can be inserted into the cartridge holder 412. This allows the connector 404 to radially snap-fit ​​even when a cartridge 8 having an axially long annular rim 82 is inserted.

[0217] With the cartridge holder 412, the body of the cartridge 8 is not held at its distal end (see FIG. 8). Without the biasing element 406, the cartridge 8 would be pushed proximally only by the plunger disk 242 touching the piston 9 of the cartridge 8. When the user installs a new needle 4, the cannula 6 pushes the cartridge 8 distally, which causes the plunger disk 242 and the piston rod 240 to push the piston 9 proximally against the body of the cartridge 8. When the cannula 6 punctures the septum, the pressure on the piston 9 can result in loss of the drug. To avoid this loss of drug, the biasing element 406 prevents axial movement of the cartridge 8 when the needle 4 is loaded into the cartridge holder 412 and / or when the cannula 6 punctures the septum of the cartridge 8.

[0218] The biasing element 406 is adapted to compensate for dimensional tolerances of the annular rim 82 of the cartridge 8, such as tolerances in its axial length and / or diameter. This is illustratively accomplished by the biasing element 406 being configured to bear against the cartridge 8 after full insertion and / or by the biasing element 406 being configured to flex radially outwardly in response to distal movement of the cartridge 8 after insertion.

[0219] The connector 404 does not bias the cartridge 8 in a proximal direction after insertion, but allows a small amount of axial movement. The biasing element 406 is configured to exert a force on the cartridge 8 that impedes movement of the cartridge 8 during attachment of the needle 4. This force may act in addition to the frictional force acting on the cartridge 8 after insertion and / or attachment of the cartridge holder 412 to the drug delivery device 200. Thus, the biasing element 406 does not completely inhibit distal axial movement of the cartridge 8 after insertion. For example, a user may still be able to move the cartridge 8 against the force of the biasing element 406.

[0220] According to other embodiments, the drug delivery device 200 may be configured as a disposable device with the cartridge holder 412 permanently and irremovably connected to the housing 210 such that the cartridge holder 412 cannot be disconnected from the housing 210 during the intended use of the device 200 and / or without destroying the device 200. For example, these embodiments may then have a cartridge holder 412 that features only the biasing element 406 and not the connector 404.

[0221] The drug delivery device 200 is a reusable device that allows for removal of a used cartridge holder 412 and reattachment of a new cartridge holder 412. As will be described in more detail below, the drug delivery device 200 is further provided in different versions adapted to deliver at least different concentrations of drugs. The different drugs are provided in cartridges 8 that are inserted into dedicated cartridge holders 412. Furthermore, the connection means 510 of the individual versions of the drug delivery device 200 and the connection means 412 of the individual versions of the cartridge holder 412 are configured as keyed connectors. Thus, the connection means 510 of each individual version of the drug delivery device 200 only connects to the connection means 414 of the specific version of the cartridge holder 412 that holds the drug to be delivered by the respective drug delivery device 200, and not to the connection means 414 of the other versions of the cartridge holder 412.

[0222] The connector 404 then prevents the removal of the cartridge 8 from its cartridge holder 412, increasing safety during use of the device 200 and the cartridge holder 412. For example, if a user accidentally obtains a cartridge holder 412 of a different version of the drug delivery device 200 than the version used by the user, those cartridge holders 412 will contain the wrong drug and will not fit into the user's drug delivery device 200 due to the keying features of the connection means 414, 510. The connector 404 then prevents the user from removing the cartridges 8 holding the wrong drug from that version of the cartridge holder 412 and inserting them into the cartridge holder 412 that is adapted for the version of the drug delivery device 200 used by the user, thus preventing the user from using the cartridges 8 with the wrong version of the drug delivery device 200 and / or from using the cartridges 8 holding the wrong drug.

[0223] Other embodiments of the cartridge holder 412 may include only the biasing element 406 and not the connector 404 , or may include only the connector 404 and not the biasing element 406 .

[0224] The proximal portion of the cartridge holder 412 further comprises an annular ridge 409 extending radially from an outer surface of the cartridge holder 412. The annular ridge 409 is configured to be engaged by a flexible locking arm of the cap 209, which is provided on an inner surface of the cap 209. The engagement between the locking arm and the annular ridge 409 releasably locks the cap 209 to the drug delivery device 200 after attachment.

[0225] According to the present disclosure, the drug delivery device 200 may be part of a set of several drug delivery devices and the dispensing unit 410 may be part of a set of several dispensing units, such that each drug delivery device only allows the attachment of its own dispensing unit and prevents the attachment of all other dispensing units of the set and vice versa, such that the connection means is configured as a keyed connection means, providing a one-to-one assignment between each dispensing unit and each drug delivery device.

[0226] The set of drug delivery devices may further include additional variations of drug delivery device 200 having at least one mutual member that is identical between drug delivery device 200 and the additional variations. The set may also include drug delivery devices of different types that do not share such mutual members with drug delivery device 200.

[0227] 36 and 37 show a set of three drug delivery devices and a set of three corresponding dispensing units according to the present disclosure, where each drug delivery device is connected to its corresponding dispensing unit by a keyed connection that prevents the respective drug delivery device from connecting to other dispensing units and conversely prevents the corresponding dispensing unit from connecting to other drug delivery devices.

[0228] Thus, Figure 36 shows a longitudinal section through the first distribution unit 420 which can be attached to the first housing 221 of the first drug delivery device 220 via the first connection means 424 of the first cartridge holder 422, a longitudinal section through the second distribution unit 430 which can be attached to the second housing 223 of the second drug delivery device 222 via the second connection means 434 of the second cartridge holder 432 of the second distribution unit 430, and a longitudinal section through the third distribution unit 440 which can be attached to the third housing 226 of the third drug delivery device 225 via the third connection means 444 of the third cartridge holder 442 of the third distribution unit 440. FIG. 37 shows side and oblique views of the first connecting means 511 of the first housing 221 of the first drug delivery device 220, the second connecting means 520 of the second housing 223 of the second drug delivery device 222, and the third connecting means 530 of the third housing 226 of the third drug delivery device 225.

[0229] The connecting means 424, 434, 444 of the cartridge holder 422, 432, 442 and the corresponding connecting means 511, 520, 530 of the drug delivery device 220, 222, 225 form a keyed connector according to the present disclosure, such that the connecting means 424, 434, 444 are of the same type and the connecting means 511, 520, 530 are also of the same type.

[0230] The respective connecting means 424, 434, 444 of the cartridge holders 422, 432, 442 each form a female part of said connection, and the respective connecting means 511, 520, 530 of the drug delivery devices 220, 222, 225 each form a corresponding male part. All connecting means 424, 434, 444, 511, 520, 530 are configured as threads, such that the connecting means 424, 434, 444 of the cartridge holders 422, 432, 442 form an internal thread and the connecting means 511, 520, 530 of the drug delivery devices 220, 222, 225 form an external thread.

[0231] The geometry of the threads 424, 434, 444, 511, 520, 530 is defined by several thread dimensions, including the core diameter or minor diameter, which specifies the minimum inner diameter of the female part of the connection, the major diameter or major diameter, which specifies the maximum inner diameter of the female part of the connection, the pitch, which specifies the distance between adjacent ridges 501 or valleys 502 of the thread, the width of a ridge 501 on the male part of the thread that corresponds to the width of a valley 502 on the female part of the thread, the opening angle between the sidewalls of adjacent ridges 501 of the male part, and the height of the ridges 501 of the male part given by the difference between the major diameter and the core diameter, and the corresponding height of the valleys 502 of the female part.

[0232] Unless otherwise stated, the term "ridge" as used in this disclosure always refers to the ridges 501 of the male threads of a given threaded connection, regardless of whether the part being described actually includes male or female threads. These ridges may also be referred to as the crests of the threaded connection. The corresponding valleys of the female threads may also be referred to as the roots of the threaded connection.

[0233] The keying is achieved by at least one of the thread dimensions, such as at least one of the core diameter, outer diameter, pitch, width and opening angle of the ridges 501 being different from each other between each pair of corresponding connection means 424, 434, 444, 511, 520, 530 of the cartridge holders 422, 432, 442 and the drug delivery devices 220, 222, 225.

[0234] According to the embodiment shown in Figures 36 and 37, the only thread dimensions that differ between the individual dispensing units 420, 430, 440, and therefore also between the individual drug delivery devices 220, 222, 225, are the width and height of the individual ridges 501 of the male part and the corresponding width and height of the valleys 502 of the female part. Thus, the ridges 501 of the first connecting means 511 have a first width w1, the ridges 501 of the second connecting means 520 have a second width w2, and the ridges 501 of the third connecting means 530 have a third width w3. The first width w1 is smaller than the second width w2, and the second width w2 is smaller than the third width w3. Exemplarily, the second width w2 is twice the first width w1, and the third width w3 is three times the first width w1.

[0235] Furthermore, the ridges 501 of the first connection means 511 have a first height h1, the ridges 501 of the second connection means 520 have a second height h2, and the ridges 501 of the third connection means 530 have a third height h3. The first height h1 is greater than the second height h2, and the second height h2 is greater than the third height h3. Thus, the second height h2 is twice the third height h2, and the first height h1 is three times the third height h3.

[0236] The aforementioned differences in heights h1, h2, h3, combined with the aforementioned differences in widths w1, w2, w3, reliably prevent the individual distribution units 420, 430, 440 from being mounted on drug delivery devices other than their corresponding drug delivery devices 220, 222, 225 having matching connection means 511, 520, 530.

[0237] The different heights h1, h2, h3 result from the different outer diameters, whereby the first outer diameter D1 of the first connecting means 424, 511 is larger than the second outer diameter D2 of the second connecting means 434, 520, which in turn is larger than the third outer diameter D3 of the third connecting means 444, 530. The first connecting means 424, 511 has a first core diameter CD1, the second connecting means 434, 520 has a second core diameter CD2, and the third connecting means 444, 530 has a third core diameter CD3, where all core diameters CD1, CD2, CD3 are equal.

[0238] According to other embodiments, the different heights h1, h2, h3 may also result from different core diameters CD1, CD2, CD3, and optionally also from different outer diameters D1, D2, D3. For example, the different heights h1, h2, h3 may result from one of the core diameters CD1, CD2, CD3 and the outer diameters D1, D2, D3 being different between the connecting means 424, 434, 444, 511, 520, 530, and the other one of the core diameters CD1, CD2, CD3 and the outer diameters D1, D2, D3 being the same between the connecting means 424, 434, 444, 511, 520, 530. According to yet another embodiment, the core diameters CD1, CD2, CD3 may be selected to be mutually identical and the outer diameters D1, D2, D3 may also be selected to be mutually identical for all connections, so that all devices 220, 222, 225 have threads 511, 520, 530 with ridges 501 of the same height.

[0239] According to the embodiment shown in Figures 36 and 37, the first pitch P1 of the first connecting means 424, 511, the second pitch P2 of the second connecting means 434, 520 and the third pitch P3 of the third connecting means 444, 530 are the same. Furthermore, the first angle A1 of the first connecting means 424, 511, the second angle A2 of the second connecting means 434, 520 and the third angle A3 of the third connecting means 444, 530 are also the same.

[0240] According to the exemplary embodiment shown in Figures 36 and 37, the individual thread dimensions may be as follows: CD1 = CD2 = CD3 = 12.60 mm, D1 = 14.70 mm, D2 = 14.00 mm, D3 = 13.30 mm, h1 = 2.10 mm, h2 = 1.40 mm, h3 = 0.70 mm, w1 = 0.65 mm, w2 = 1.30 mm, w3 = 1.95 mm, A1 = A2 = A3 = 60°. Thus, the pitches of the individual threads may all be P1 = P2 = P3 = 3.80 mm.

[0241] The thread dimensions may also be as follows: CD1=CD2=CD3=12.60mm, D1=14.70mm, D2=14.00mm, D3=13.30mm, h1=1.05mm, h2=0.70mm, h3=0.35mm, w1=0.65mm, w2=1.30mm, w3=1.95mm, A1=A2=A3=60°. The pitches of the individual threads may all be P1=P2=P3=3.80mm.

[0242] Alternatively, the above dimensions of the thread ridge width w may be applied to the thread root width g instead of the thread ridge width w. Thus, an individual thread root width g may be defined as the bottom section of a thread groove that lies on the core diameter and extends between the angled flanks that bound the thread ridges, as shown in Figures 58 and 59.

[0243] The thread dimensions may then be as follows: CD1=CD2=CD3=12.60 mm, D1=14.70 mm, D2=14.00 mm, D3=13.30 mm, h1=1.05 mm, h2=0.70 mm, h3=0.35 mm, g1=1.95 mm, g2=1.30 mm, g3=0.65 mm, A1=A2=A3=60°, and P1=P2=P3=3.80 mm. According to this embodiment, the widths w of the ridges of the male threads may be w1=1.84 mm, w2=2.50 mm, and w3=3.15 mm. Thus, the width w of the ridges is defined as the width including the top surface that defines the outer diameter D and the side surfaces that connect each top surface to the adjacent valley, both of which are angled. The width w is therefore w=Pg. These dimensions are shown in FIG. 58 which shows the distribution units 420 , 430 , 440 and in FIG. 59 which shows the corresponding connection means 511 , 520 , 530 of the distribution units 220 , 222 , 225 .

[0244] Generally, among a set of N drug delivery devices 200, the Nth device may have threads with ridges having a width that is N times the width of the thread ridges of the first device, and the first device may have threads with ridges having a height that is N times the height of the ridges of the Nth device, then the mth device (where 1≦m≦N) may have threads with ridges having a width that is m times the width of the thread ridges of the first device, and a height that is (N-m+1) times the height of the ridges of the Nth device.

[0245] Alternatively, the above relationship may be applied to the male thread root width g instead of the male thread ridge width w. Thus, a first device may have a thread with a root width g that is N times the thread root width g of the Nth device, and the first device may have a thread with a ridge height that is N times the ridge height of the Nth device. Then, an mth device (where 1≦m≦N) may have a thread with a root width that is (N-m+1) times the thread root width g of the Nth device, and a height that is (N-m+1) times the thread ridge height of the Nth device.

[0246] In one embodiment, the first drug delivery device 220, the second drug delivery device 222 and the third drug delivery device 225 are each a variation of the drug delivery device 200 disclosed in connection with FIGS. 1-35. Unless a difference is stated or is apparent from the figures, the first drug delivery device 220, the second drug delivery device 222 and the third drug delivery device 225 are configured as disclosed in connection with the drug delivery device 200, and vice versa. Furthermore, the first distribution unit 420, the second distribution unit 430 and the third distribution unit 440 are each a variation of the distribution unit 410 disclosed in connection with FIGS. 1-35. Unless a difference is stated or is apparent from the figures, the first distribution unit 420, the second distribution unit 430 and the third distribution unit 440 are configured as disclosed in connection with the distribution unit 410, and vice versa.

[0247] The second drug delivery device 222 and the first drug delivery device 220 share at least one mutual member that is identical between the first drug delivery device 220 and the second drug delivery device 222, and the third drug delivery device 225 and the first drug delivery device 220 share at least one further mutual member that is identical between the first drug delivery device 220 and the third drug delivery device 225. Thus, the mutual member and the further mutual member are identical. According to other embodiments, the mutual member and the further mutual member may also be different. Thus, the mutual members are mechanically identical in both, i.e., are identical in shape and are identical in their appearance, such as their color and printing.

[0248] The second drug delivery device 222 and the first drug delivery device 220 each comprise at least one distinguishing member that differs between the first drug delivery device 220 and the second drug delivery device 222, and the third drug delivery device 225 and the first drug delivery device 220 each comprise at least one further distinguishing member that differs between the first drug delivery device 220 and the third drug delivery device 225. Thus, the distinguishing member and the further distinguishing member are the same functional member and therefore perform the same function during use of the administration mechanism. According to other embodiments, the mutual member and the further mutual member may also be different functional members.

[0249] The distinguishing members differ at least in their appearance, such as color and printing. Additionally, the distinguishing members may also differ mechanically, i.e., in shape. Despite the differences in appearance and optionally shape, the individual distinguishing members perform the same function during dose setting and dose delivery, and thus constitute the same functional member among the individual drug delivery devices 220, 222, 225. Thus, the individual distinguishing elements are designated by the same term in all drug delivery devices 200, 220, 222, 225.

[0250] The functional members constitute the individual parts from which the drug delivery devices 220, 225, 225 are assembled. The individual parts may differ in exact shape and appearance, for example to provide different dose increments between the individual drug delivery devices 220, 225, 225, but they perform the same function and are located at the same position in the dosing mechanism 230 of the individual drug delivery devices 220, 225, 225. Moreover, they interact and engage with the same further functional members of the dosing mechanism 230 between all drug delivery devices 220, 225, 225 of the set. The functional member may be composed of several subparts rigidly connected to each other to form a single machine part. According to one embodiment of the present disclosure, the dosing member may constitute a functional member composed of, for example, two subparts, namely a dose sleeve and a snap element.

[0251] The first drug delivery device 220 and the second drug delivery device 222 form a first set of drug delivery devices which are mechanically different only by their outer housings 221, 223 carrying the keyed connecting means 510, 520. All other functional members of the first set of drug delivery devices 220, 222 are mechanically identical. Thus, the dosing mechanism 240, the clutch mechanism 234 and the dose defining mechanism 232 of the two drug delivery devices 220, 222 are also the same. Thus, the two drug delivery devices 220, 222 define identical rotational dose positions of the dose setting member 290 and are configured to eject the same amount of liquid per settable dose increment.

[0252] One of the first set of drug delivery devices 220, 222 is configured to be used with its corresponding dispensing unit 420, 430 that contains a drug having a first concentration of the active pharmaceutical ingredient, and the other one of the first set of drug delivery devices 220, 222 is configured to be used with its corresponding dispensing unit 420, 430 that contains a drug having a second concentration of the active pharmaceutical ingredient that is different from the first concentration.

[0253] Between the first set of drug delivery devices 220, 222, the piston rod 240, the plunger disc 242, the driver 350, the nut 250, the dose setting member 290, the first bearing element 370 and the second bearing element 380, the biasing member 308, the inner housing 180, and all elements of the reset mechanism 110, i.e., the reset element 110, the coupling portion 130 and the biasing member 150, each form mutual members that are mutually identical in both appearance and shape between the two drug delivery devices 220, 222.

[0254] The dosing members 330 of the two drug delivery devices 220, 222 of the first set form visually different but not shaped differentiating members between the two drug delivery devices 220, 222. Thus, the visual difference includes different numbers of the visual indicia 331, such that each indicia 331 is located at the same position on the dosing members 330 of each of the two drug delivery devices 220, 222.

[0255] The outer housings 211 of the two drug delivery devices 220, 222 of the first set form differently shaped distinguishing elements due to the difference in their connecting means 511, 520. Furthermore, the outer housings 211 differ in appearance, such as in color and / or labeling, to allow a user to clearly distinguish between the two devices 220, 222.

[0256] The dose selector member 310 and the cap 209 of the two drug delivery devices 220, 222 of the first set also form distinguishing members that are visually different between the two drug delivery devices 220, 222 but not different in shape. Thus, the visual difference includes different labeling on the dose selector member 310 and the cap 209. Furthermore, the cap 209 differs in color to match the color of the respective body of those drug delivery devices 220, 222. According to other embodiments, the dose selector member 310 and / or the cap 209 may also be configured as mutual members. Furthermore, the cap 209 may also differ only in color and not in labeling, or vice versa.

[0257] Each of the first drug delivery device 220 and the second drug delivery device 222, together with the third drug delivery device 225, form a second set of drug delivery devices 200, 220, 225 which are mechanically different not only in their outer housings 211 but also in the functional members of their administration mechanisms 230, in particular their dose-regulating mechanisms 232.

[0258] The dosing mechanism 230 of the third drug delivery device 225 is configured to provide a dial rotation resolution different from the dial rotation resolution of the first drug delivery device 220 and the second drug delivery device 222. While the dosing mechanism 230 of the first drug delivery device 220 and the second drug delivery device 222 comprise a dose selector member 310 and a dose setting member 290 as described in relation to Figures 1 to 35 configured to define 27 settable dose positions, the third drug delivery device 225 comprises an embodiment of a dose selector member 310 and a dose setting member 290 configured to define 18 settable dose positions.

[0259] The dose selector member 310 of the third drug delivery device 225 comprises eighteen functional features 312 distributed over its inner surface. Thus, the position of the elastic elements 292 of the dose setting member 290 is adapted to a larger distance between the individual functional features 312 to enable reliable engagement between the elastic elements 292 and the functional features 312.

[0260] Since the dose setting mechanism 332 of the third drug delivery device 225 sets even settable doses, the connection 277 between the clutch member 270 and the dose setting member 290 is configured to connect the clutch member 270 and the dose setting member 290 in two different relative rotational orientations that differ from each other by 180°. To achieve this, the first and second longitudinal grooves 297 and 298 of the dose setting member 290 and the corresponding first and second ridges 279 and 280 of the clutch member 270 each have the same width.

[0261] The clutch member 270 of the third drug delivery device 225 comprises eighteen clutch elements 273 whose circumferential positions are adapted to the circumferential positions of the functional features 312 of the dose selector member 310. Thus, the number and circumferential positions of the clutch elements 273 of the clutch member 270 of the third drug delivery device 225 are different from the number and circumferential positions of the clutch elements 273 of the clutch member 270 of the first drug delivery device 220 and the second drug delivery device 222.

[0262] The clutch member 270 of the first drug delivery device 220 and the second drug delivery device 222 on the one hand and the clutch member 270 of the third drug delivery device 225 on the other hand form a differentiating member whose shape differs between the second set of drug delivery devices 220, 222, 222, 225. Similarly, the dose setting member 290 of the first drug delivery device 220 and the second drug delivery device 222 on the one hand and the dose setting member 290 of the third drug delivery device 225 on the other hand also form a differentiating member whose shape differs between the second set of drug delivery devices 220, 222, 225.

[0263] The dosing member 330 of the third drug delivery device 225 comprises eighteen clutch elements 336 whose circumferential positions are adapted to the circumferential positions of the clutch elements 273 of the clutch member 270. Thus, the dosing member 330 of the third drug delivery device 225 and each of the dosing members 330 of the first drug delivery device 220 and the second drug delivery device 222 form a differentiating member whose shape differs between the second set of drug delivery devices 220, 222, 225.

[0264] Generally, the clutch mechanism 234 of the first drug delivery device 220 and the clutch mechanism 234 of the second drug delivery device 222 are configured to pivotally couple the nut 250 to the dosing member 330 and / or the housing 210 in the same relative rotational position. The clutch mechanisms 234 of the first drug delivery device 220 and the second drug delivery device 222 on the one hand and the clutch mechanism 234 of the third drug delivery device 225 on the other hand are configured to pivotally couple the nut 250 to the dosing member 330 and / or the housing 210 in different relative rotational positions.

[0265] Similarly, the clutch mechanism 234 of the first drug delivery device 220 and the clutch mechanism 234 of the second drug delivery device 222 are configured to pivotally couple the dose setting member 290 to the dosing member 330 and / or the housing 210 in the same relative rotational position. The clutch mechanisms 234 of the first drug delivery device 220 and the second drug delivery device 222 on the one hand and the clutch mechanism 234 of the third drug delivery device 225 on the other hand are configured to pivotally couple the dose setting member 290 to the dosing member 330 and / or the housing 210 in different relative rotational positions.

[0266] According to all drug delivery devices 200, 220, 222, 225, the clutch element 273 of the clutch member 270, the clutch element 336 of the dispensing member 330, the clutch element 312 of the dose selector member 310 and the clutch element 294 of the dose setting member 290 are rotatably aligned relative to each other such that at each rotational position of the dose setting member 290 where the clutch element 273 of the clutch member 270 and the clutch member 336 of the dispensing member 360 are aligned with each other to enable mutual engagement, the clutch element 294 of the dose setting member 290 and the clutch element 312 of the dose selector member 310 are also aligned with each other to enable mutual engagement.

[0267] Furthermore, to reflect the different number of doses that can be set per rotation of the dose setting member 290, the position of the optical marker 331 on the dosing member 330 of the third drug delivery device 225 differs from the position of the optical marker 331 on the dosing member 330 of the first drug delivery device 220 and the second drug delivery device 222, so that the dosing member 330 of the third drug delivery device 225 looks different from the dosing member 330 of the first drug delivery device 220 and the second drug delivery device 222.

[0268] The numbering of the individual optical markers 331 on the dosing member 330 of the first drug delivery device 220 is different from the numbering of the individual optical markers 331 on the dosing member 330 of the third drug delivery device 225. This allows the first drug delivery device 220 to be used with a drug having a first concentration of active pharmaceutical ingredient and the third drug delivery device 225 to be used with a drug having a third concentration of active pharmaceutical ingredient, such that a first concentration product with an amount of liquid ejected by the first drug delivery device 220 per dose increment is different from a third concentration product with an amount of liquid ejected by the third drug delivery device 225 per dose increment.

[0269] The numbering of the individual optical markers 331 on the dosing member 330 of the second drug delivery device 222 is equal to the numbering of the individual optical markers 331 on the dosing member 330 of the third drug delivery device 225. This allows the second drug delivery device 220 to be used with a drug having a second concentration of active pharmaceutical ingredient and the third drug delivery device 225 to be used with a drug having a third concentration of active pharmaceutical ingredient, such that the second concentration product with the amount of liquid expelled by the second drug delivery device 222 per dose increment is equal to the third concentration product with the amount of liquid expelled by the third drug delivery device 225 per dose increment.

[0270] Due to the difference in shape and appearance, the dosing member 330 constitutes a differentiating member between the second set of drug delivery devices 220 , 222 , 225 .

[0271] Collectively, the second set of interlocking components of the drug delivery devices 220, 222, 225 are the piston rod 240, the plunger disc 242, the nut 250, the driver 350, the bearing elements 370, 380, the biasing member 308, the inner housing 180, and all the elements of the reset mechanism 110, i.e., the reset element 110, the coupling portion 130 and the biasing member 150.

[0272] The distinguishing members which differ only in appearance but not in shape among the second set of drug delivery devices 220, 222, 225 are the caps 209 each having a different color. The distinguishing members which differ both in appearance and shape among the second set of drug delivery devices 220, 222, 225 are the outer housings 211 each having a different color and different shape of the connecting means 511, 520, 530, the dosing members 330 each having a different position and / or number and / or labelling of their optical markers 331 and different shape of the clutch elements 336, the dose selector members 310 each having a different labelling and different amount of functional features 312, the clutch members 270 which differ in shape and / or number of their clutch elements 273 and therefore differ in their appearance, and the dose setting members 290 which differ in the position of their elastic elements 292 and their clutch elements 294 and therefore differ in their appearance.

[0273] The first drug delivery device 220 is configured for use with a drug comprising an active pharmaceutical ingredient in a concentration of 5 mg / 1.5 ml, the second drug delivery device 222 is configured for use with a drug comprising an active pharmaceutical ingredient in a concentration of 10 mg / 1.5 ml, and the third drug delivery device 225 is configured for use with a drug comprising an active pharmaceutical ingredient in a concentration of 15 mg / 1.5 ml. Both the first drug delivery device 220 and the second drug delivery device 222 have a dial rotation resolution of 0.015 ml per dose increment, and the third drug delivery device 225 has a dial rotation resolution of 0.010 ml per dose increment.

[0274] The optical marker 331 on the dosing member 330 of the first drug delivery device 220 then indicates a dose increment of 0.05 mg, and the optical marker 331 on the dosing member 330 of the second drug delivery device 222 and the third drug delivery device 225 then each indicates a dose increment of 0.10 mg. All drug delivery devices 220, 222, 225 allow two complete rotations of the dose setting member 290 during dose setting. With 27 dose increments per rotation of the dose setting member 290, the first drug delivery device 220 is configured to eject a maximum dose of 1.80 mg of active pharmaceutical ingredient, and the second drug delivery device 222 is configured to eject a maximum dose of 3.60 mg of active pharmaceutical ingredient. The third drug delivery device 225 is configured to deliver a maximum dose of 5.40 mg of active pharmaceutical ingredient, providing 18 dose increments per rotation of the dose setting member 290.

[0275] The reset mechanism according to the present disclosure is also applicable with other drug delivery devices, for example injection devices. A further possible injection device is a pen-type further drug delivery device 10 illustrated in Figures 38-40. Unless differences are stated or are clear from the figures, the further drug delivery device 10 is now configured as disclosed in relation to the drug delivery device 200 and vice versa. The further drug delivery device 10 is also described in more detail in WO 2020 / 015980 and WO 2019 / 011394, the disclosures of each of which are incorporated by reference in their respective entireties into the present disclosure.

[0276] The further drug delivery device 10 has an outer housing 3 connected to a dispensing unit 410 having a cartridge holder 2 holding a cartridge 8. The cartridge holder 2 has a needle connector 402. The injection device 10 has a dosing mechanism 30 and is illustrated in a zero dose state as indicated by an optical marker 40 showing zero through a window 3a in the outer housing 3. At its proximal end, the outer housing 3 terminates in a keyed connection means 510 having the form of a screw thread.

[0277] 40 shows generally a simplified exploded view of device 10 with cap 1 removed to expose cartridge holder 2 and proximal needle connector 402. Needle 4 is attached to needle connector 402, typically through a snap fit, threads, Luer Lock™, or other secure attachment with hub 5, such that double ended needle cannula 6 can achieve fluid communication with a drug contained in a cartridge 8 positioned within cartridge holder 2.

[0278] The particular design of the device 10 allows the setting of one or more of the predefined fixed doses through interaction of the snap element 33 with the dose selector member 35. Rotation of the dose setting member 31 and the snap element 33 takes place during dose setting and is relative to the outer housing 3. During the initiation of a dose delivery procedure, the dose setting member 31 is pushed in a proximal direction and the dose setting member and the dose selector member 35 are moved axially relative to the snap element 33. Similar to the drug delivery device 200, the dose selector member 35 is axially movable and pivotally fixed relative to the outer housing 3 of the further drug delivery device 10.

[0279] Part of the dosing mechanism of most pen injectors, including device 10, is the piston rod 42 as shown in FIG. 40. The piston rod 42 has a non-circular cross section and two flat surfaces designed to prevent the piston rod 42 from rotating relative to the outer housing 3, but allow the piston rod to move linearly in the proximal direction. The nut 36 and the clutch member 32 are permanently splined to each other during assembly of the dosing mechanism 30 through a spline connection 37. The spline connection 37 ensures that the clutch member 32 and the nut 36 are always rotationally fixed to each other during both dose setting and dose delivery. This spline connection 37 also allows the clutch member 32 and the nut 36 to move axially relative to each other during both dose setting and dose delivery.

[0280] The proximal end of the nut 36 has an internal thread that mates with a corresponding external thread 60 of the piston rod 42. The distal end of the clutch member 32 is configured as a dose button 61 and is permanently attached to the distal end of the dose setting member 31 through engagement of a connector, which may be configured as a snap lock, adhesive and / or sonic welding. This connection ensures that the clutch member 32 is both rotationally and axially fixed to the dose setting member 31 relative to one another during both dose setting and dose delivery. Alternatively, the clutch member 32 and the dose setting member 31 may also be configured as a single member.

[0281] At the proximal end of the piston rod 42 is a connector configured as a snap fit that connects with the plunger disk or foot 42a. At the distal end of the piston rod 42 is a stop feature 63 of the dosing mechanism 30, illustrated as an enlarged section. This enlarged section 63 is designed to stop the rotation of the nut 36 around the thread 60 when the amount of drug remaining in the cartridge 8 is less than the next higher predetermined dose setting. In other words, if the user attempts to set one of the predetermined fixed dose settings that exceeds the amount of drug remaining in the cartridge 8, the enlarged section 63 acts as a hard stop that prevents the nut 36 from rotating further along the thread 60 as the user attempts to reach the desired predetermined fixed dose setting. According to the drug delivery device 200, the stop feature 243 interacts with the nut 250 in the same manner, thus also preventing a dose being set that is greater than the remaining dose in the cartridge 8.

[0282] The piston rod 42 is held non-rotating relative to the outer housing 3 during both dose setting and dose delivery by the piston rod guide 43. The piston rod guide 43 is fixed to the outer housing 3 both rotationally and axially. The piston rod guide thus forms part of the housing of the device 10. This fixation can be achieved when the piston rod guide 43 is a separate component from the outer housing 3 as illustrated, or the piston rod guide 43 can be made integral with the outer housing 3, similar to the inner sleeve 183 of the inner housing 180 of the drug delivery device 200. Although not shown in the figures, the piston rod guide 43 may be configured as a reset mechanism, like the reset mechanism 100 of the drug delivery device 200, which prevents rotation of the piston rod 42 relative to the housing 3 when the dispensing unit 410 is attached to the housing 3 of the drug delivery device 10, and allows rotational movement of the piston rod 42 relative to the housing 3 when the dispensing unit 410 is disengaged from the housing 3.

[0283] The reset mechanism of the further drug delivery device 10 may be configured as disclosed in relation to the reset mechanism 100 of the drug delivery device 200. In particular, the reset mechanism of the further drug delivery device 10 may comprise a reset element 110, a coupling portion 130 and a biasing element 150.

[0284] The piston rod guide 43 also engages the proximal end of a pivot biasing member 90, shown as a torsion spring, the function of which is described below. This connection of the pivot biasing member 90 to the piston rod guide 43 fixes one end of the pivot biasing member 90 in a pivotally fixed position relative to the outer housing 3.

[0285] The distal end of the pivot biasing member 90 is connected to a driver 41. The driver 41 is connected to and pivotally fixed to the inner surface of the dispensing member 330 through a splined connection on the distal outer surface of the driver 41. The splined connection comprises at least one longitudinal ridge, such as two, located on the outer diameter of the driver 41, which engages with a corresponding groove on the inner surface of the dispensing member 330. On the proximal end of the driver 41 on its outer surface are threads 67 that engage with matching threads on the distal inner surface of the piston rod guide 43.

[0286] The dosing member 330 comprises two parts which are pivotally and axially fixed to one another, for example by a snap-fit ​​connection: one part forms the dosing sleeve 38 which is connected to the driver 41 through a spline connection, the other part forms the snap element 33. The dosing member 330 therefore forms a single functional member.

[0287] The dosing member 330, i.e. the dosage sleeve 38, is threadedly engaged with the body 3 by a helical groove 39 located on the outer surface of the dosing member 330, which engages with a corresponding helical ridge located on the inner surface of the body 3. The thread between the driver 41 and the piston guide 43 has a significantly different pitch than the thread between the dosing member 330 and the outer housing 3. The axial sliding connection between the nut 36 and the clutch member 32 makes it possible to compensate for the difference in the pitch of the thread between the inner surface of the nut 36 and the outer surface of the piston rod 42 and the pitch of the thread between the dosing member 330 and the body 3. The thread between the driver 41 and the piston guide 43 has essentially the same pitch as the thread between the piston rod 42 and the nut 36.

[0288] The nut 36 and the driver 41 rotate together during both dose setting and dose cancelling, and therefore they perform essentially the same axial movement. However, these movements are independent of each other, i.e. the nut 36 is turned by the clutch member 32 and performs an axial movement relative to the piston rod 42 due to the threads, while the driver 41 is turned by the dosing member 330 and performs an axial movement relative to the piston guide 43 due to the threads. The driver 41 also rotates during injection and therefore effectively moves in the proximal direction during injection. However, the nut 36 does not rotate during injection and therefore does not perform an effective axial movement. The nut 36 only moves in the proximal direction during injection, since it is pushed axially by the driver 41, which surrounds the nut 36 and abuts against the projection 64 located at the proximal end of the nut 36. Injection is performed because the rotating driver 41 pushes against the non-rotating nut 36, which pushes the piston rod 42 forward due to its threaded engagement with the nut 36.

[0289] Because the torsion spring 90 is attached to the driver 41, which is pivotally fixed to the dispensing member 330, rotation of the dispensing member 330 in a first direction during dose setting causes the torsion spring 90 to wind up, thereby exerting a counter-rotational force on the dispensing member 330 in an opposite second direction. This counter-rotational force urges the dispensing member 330 to rotate in the dose cancelling direction.

[0290] Generally, the further drug delivery device 10 comprises a biasing member, exemplarily configured as a torsion spring 90, which is prestressed upon an increase in the set dose. Moreover, the biasing member is released during the dose delivery. Thus, the biasing member at least assists in the delivery of the set dose by providing a force that advances the piston rod 60 in a proximal direction. Such a biasing member may also be provided in the drug delivery device 200. For example, the biasing member may also be provided between the inner housing 180 and the driver 350 of the device 200 and configured as a torsion spring acting between the inner housing 180 and the driver 350 in the same way that the torsion spring 90 acts between the piston guide 43 and the driver 41 of the further drug delivery device 10.

[0291] The further drug delivery device 10 as a whole and the function of the dosing mechanism 30 will now be described. The further drug delivery device 10 is provided to the user as a reusable or semi-reusable device. Semi-reusable means that only the dosing mechanism 30 housed in the outer housing 3 is reusable each time a new dispensing unit 410 with a cartridge holder 2 containing a new cartridge 8 of medicament is connected to the outer housing 3. A reusable device allows the user to reattach the old or previously used cartridge holder 2 when inserting a new full cartridge 8 of medicament. In one configuration according to the present disclosure, the device 10 has a semi-reusable design, where the user needs to disconnect the cartridge holder 2 containing the empty cartridge 8, which is not removable from the cartridge holder 2, each time the medicament in the cartridge 8 is expelled or emptied. Thus, the user will discard both the cartridge holder 2 and the empty cartridge 8 together. The new cartridge holder 2 and cartridge 8 assembly is connected to the outer housing 3, provided that the keyed connection means 510 on the outer housing 3 matches the keyed connection means 414 provided on the distal end of the cartridge holder 2.

[0292] According to a further drug delivery device 10, the dose sleeve 38 and the snap element 33 are axially and rotatably fixed to one another via a snap-fit ​​connection. The dose sleeve 38 and the snap element 33 therefore constitute a single functional element, namely the dosing member 330. According to other embodiments of the further drug delivery device 10, the dosing member 330 may also be configured as a single component or member.

[0293] The housing of the further drug delivery device 10 comprises an outer housing 3 and a piston guide 43 which are rotatably and axially fixed relative to each other.

[0294] Similar to the drug delivery device 200, the further drug delivery device 10 comprises a clutch mechanism 237. During dose setting, the clutch mechanism 237 pivotally fixes the nut 36 relative to the driver 41 and the dosing member 330, while allowing rotation of the nut 36 relative to the housing 3, 43. During dose delivery, the clutch mechanism 237 pivotally fixes the nut 36 relative to the dose selector member 35 and the housing 3, 43, while allowing relative rotation between the nut 36 on the one hand and the driver 41 and the dosing member 330 on the other hand.

[0295] As can be seen in Figures 41 and 42, a first part 238 of the clutch mechanism 237 is configured as radially extending teeth and comprises a clutch element 33a provided on an outer surface at the distal end of the snap element 33 of the dispensing member 330. A second part 239 of the clutch mechanism 237 is configured as radially extending teeth and comprises a clutch element 34a provided on an outer surface at the distal end of the connector 34.

[0296] The connector 34 is located in an annular recess of the dosing member 330 and is thus pivotally movable and axially fixed relative to the dosing member 330. The connector 34 is axially movable and pivotally fixed relative to the dose selector member 35. This is exemplarily achieved by a radially protruding ridge 34b of the connector 34 that is received in a corresponding longitudinal groove on the inner surface of the dose selector member 35. The pivotally fixed connection to the dose selector member 35 also pivotally fixes the connector 34 to the housing 3, 34 of the further drug delivery device 10.

[0297] The dispensing member 330 surrounds the clutch member 32, which together with the dose setting member 31 and the dose selector member 35 is axially movable relative to the dispensing member 330. The dose setting member 31 and the clutch member 32 are thus biased in the distal direction by a compression spring 91 (shown in FIG. 40 ) acting between the dispensing member 330 and the clutch member 32. Axial movement in the proximal direction of the clutch member 32 and the dose setting member 31 is allowed until the dose setting member 31 pushes the dispensing member 330 through the clutch member 32. Thus, the push member 32a, exemplarily configured as a ridge protruding from the outer surface of the cylindrical part of the clutch member 32, pushes the dispensing member 330, i.e. the distal end of the snap element 33.

[0298] During dose setting, the clutch member 32 and the dose setting member 31 are in their distal position relative to the dispensing member 330. In this position, the dose setting member 31 is pivotally coupled to the dispensing member 330 via a first part 238 of the clutch mechanism 237, which comprises a clutch element 33a at the distal end of the snap element 33 of the dispensing member 330 and a corresponding clutch element 31a on the inner surface of the dose setting member 31, as shown in FIG. 42. When the dose setting member 31 is rotated during dose setting, the dispensing member 330 is also rotated and screwed out of the outer housing 3 via the closed first part 238 of the clutch mechanism 237 between the dose setting member 31 and the dispensing member 330. This also forces the dose selector member 35 and the dose setting member 31 to move in a distal direction. The rotation of the dispensing member 330 also forces the driver 41 to rotate correspondingly, and thus also to be screwed out of the piston guide 43.

[0299] Since the nut 36 is rotatably fixed to the clutch member 32, during dose setting, rotation of the dose setting member 31 also rotates the nut 36. Thus, the nut 36 is threadably moved along the piston rod 42, also moving in the distal direction. The pitch of the threads of the piston rod 42 and the driver 41 is adapted so that the nut 36 and the driver 41 essentially move the same axial distance upon rotation. Thus, the nominal pitch of the connection between the driver 41 and the piston guide 43 is slightly higher than the nominal pitch of the threads between the piston rod 42 and the nut 36, in order to prevent mutual blocking of the nut 36 and the driver 41 regardless of manufacturing tolerances.

[0300] To expel the set dose, the dose setting member 31, the clutch member 32 and the dose selector member 35 are moved to their distal positions relative to the dispensing member 330. This releases a first part 238 of a clutch mechanism 237 between the snap element 33 of the dispensing member 330 and the dose setting member 31 and engages a second part 239 of the clutch mechanism 237, which is realised between the dose setting member 31 and the connector 34 surrounding the dispensing member 330. Upon engagement of the second part 239 of the clutch mechanism 237, the clutch element 31a of the dose setting member 31 engages with the clutch element 34a of the connector 34.

[0301] Engagement of the second part 239 of the clutch mechanism 237 pivotally locks the dose setting member 31 and the clutch member 32 to the connector 34 and, via the ridge 34b of the connector 34, also to the dose selector member 35 and the housing 3, 43. The nut 36 is therefore pivotally locked relative to the housing 3, 43 and the piston rod 42 during dosing. This locking is achieved via the nut 36, the clutch member 32, the dose setting member 31, the connector 34 and the dose selector member 35.

[0302] Disengagement of the first part 238 of the clutch mechanism 237 allows pivotal movement between the nut 36 and the driver 41 and dispensing member 330 during dose delivery.

[0303] Further pushing of the dose setting member 31 in the proximal direction causes the clutch member 32 to abut against the dispensing member 330 and to force the dispensing member 330 to move in the proximal direction. Due to the threaded connection between the dispensing member 330 and the outer housing 3, the dispensing member 330 rotates when moving in the proximal direction. This rotation is transmitted to the driver 41, which is screwed into the piston guide 43 in the proximal direction and thus also moves axially in the proximal direction. Thus, the driver 41 abuts against and advances the nut 36, which is now rotatably fixed to the outer housing 3 and the piston rod 42 via the clutch member 32, the dose setting member 31, the connector 34 and the dose selector member 35. Thus, both the piston rod 42 and the nut 36 are rotatably fixed relative to each other, and the axial advancement of the nut 36 causes a corresponding axial advancement of the piston rod 42, thus expelling the set dose.

[0304] Similar to the drug delivery device 200, the further drug delivery device 10 may also comprise one or more friction reducing mechanisms for reducing friction within the dosing mechanism 30 during delivery of the set dose. These friction reducing mechanisms may be configured in the same manner as those disclosed in relation to the drug delivery device 200.

[0305] For example, the first friction reducing mechanism may be provided between an actuating member of the further drug delivery device 10 formed by the clutch member 32 and the dosing member 330. The clutch member 32 acts as an actuating member providing a proximal force to effect delivery of the set dose when a user pushes a distal portion of the clutch member 32.

[0306] Thus, the first friction reducing mechanism may be directly contacted by the clutch member 32 and the dispensing member 330. For example, the friction reducing mechanism may be provided between a distal end of the dispensing member 330 and the protruding ridge 32a of the clutch member 32.

[0307] According to further embodiments of the drug delivery device 10, the first friction-reducing mechanism provided between the actuation member and the dosing member 330 may also be contacted via one or more intermediate members. For example, the first friction-reducing mechanism may be provided between the dose selector member 35 and the dosing member 330. When pushing the clutch member 32 in the proximal direction and thus also the dose setting member 31, the dose selector member 35, e.g. the proximal end of the dose selector member 35, may abut against the dose sleeve 38, e.g. the distal end of the dose sleeve 38. At this time, the first friction-reducing mechanism, such as a ball bearing 370, may be provided between the dose selector member 35 and the dose sleeve 38, e.g. between the proximal end of the dose selector member 35 and the distal end of the dose sleeve 38.

[0308] Additionally or alternatively, a second friction reduction mechanism may be provided between the driver 41 and the nut 36 in the same manner as disclosed in connection with the second friction reduction mechanism, such as the disk bearing 380, of the drug delivery device 200.

[0309] The further drug delivery device 10 comprises a dose setting mechanism 232 acting between a dosing member 330 and a dose selector member 35. During dose setting, the dosing member 330 rotates relative to the dose selector member 35. As can be seen in Fig. 41, the dosing member 330, i.e. the snap element 33, has on its outer surface a flexible arm 33c which forms a resilient element and has a radial projection 33d which engages with a dose stop 35a on the inner surface of the dose selector 35. The dose stop 35a shown in Fig. 43 forms a functional feature 312 of the dose setting mechanism 232.

[0310] The circumferential position of each dose stop 35a thus defines a respective relative rotational position between the dosing member 330 and the housing 3, 43, which corresponds to a settable dose. To prevent dial rotation of intermediate doses between the individual dose stops 35a, a torsion spring 90 is provided between the piston guide 43 and the driver 41. This torsion spring 90 is loaded when increasing the set dose and causes the dosing member 330 to rotate back to the last set dose if the dose setting member 31 is released while the projection 33d on the dosing member 330 is positioned between two dose stops 35a.

[0311] According to a further drug delivery device 10, the dosing member 330 is limited to perform less than one full rotation following dose setting. The further drug delivery device 10 comprises a stop mechanism defining maximum and minimum rotation positions of the dosing member 330 during dose setting.

[0312] The stop mechanism acts between the snap element 33 of the dispensing member 330 and the dose selector member 35. The stop mechanism comprises a further protrusion 33f located on the outer surface of the dispensing member 330 and protruding radially towards the dose selector member 35. The dose selector member 35 comprises a maximum stop feature 35b located on an inner surface of the dose selector member 33 and configured as a side of a step located on the inner surface. Furthermore, the dose selector member 35 comprises a zero stop feature 35c also located on the inner surface of the dose selector member 33. The zero stop feature 35c is exemplarily configured as a side of a step opposite the side forming the maximum stop feature 35b. According to other embodiments of the dose selector member 33, the zero stop feature 35c and the maximum stop feature 35b may also be provided in separate protrusions or steps on the inner surface of the dose selector member 33.

[0313] The further protrusion 33f of the dispensing member 330 is configured to abut against the maximum stop feature 35b upon rotation of the dispensing member 330 to a rotation position corresponding to or exceeding the maximum settable dose, thereby preventing further rotation of the dispensing member 330. Similarly, the further protrusion 33f of the dispensing member 330 is configured to abut against the zero stop feature 35c upon rotation of the dispensing member 330 to a rotation position corresponding to a zero dose setting, thereby preventing further rotation of the dispensing member 330.

[0314] The further drug delivery device 10 may also comprise alternative embodiments of a stop mechanism defining a maximum dose position and / or a zero dose position of the dosing member 330 relative to the housing 3, 43. The alternative embodiments may be configured like the stop mechanism of the drug delivery device 200. Thus, a maximum dose stop may be provided on the dosing member 330, such as the dose sleeve 38 or the snap element 33, and a corresponding maximum stop feature may be provided on the housing 3, 43. The maximum dose stop and / or maximum stop feature may be configured as described in relation to the maximum dose stop 337 and the maximum stop feature 190 of the drug delivery device 200.

[0315] Similarly, alternative embodiments of the stop mechanism of the further drug delivery device 10 may comprise a zero dose stop provided on the dosing member 330, such as the dose sleeve 38 or the snap element 33, and a corresponding zero stop feature provided on the housing 3, 43, for example on the piston guide 43. The zero dose stop and / or the zero stop feature may be configured as described in relation to the maximum dose stop 337 and maximum stop feature 190 of the drug delivery device 200.

[0316] Similar to the drug delivery device 200, the further dose delivery devices 10 may be provided in several variants distinguished by their connection means 510, in order to be configured to connect only to a dedicated variant of the dispensing unit 410. Thus, the connection means 510 may be configured as disclosed in relation to Figures 36 and 37.

[0317] In one embodiment, some variants of the further drug delivery device 10 comprise the outer housing 3, the cap 1, the dose sleeve 38 and the dose selector member 35 as distinguishing members. The outer housing 3 differs in shape due to differences in the connection means 510 and also differs in appearance due to different colors and / or labeling. The dose selector member 35 differs in shape due to different numbers and / or different positions of the dose stops 35a, which allows to achieve different dial rotation resolutions or settable doses. Alternatively or additionally, the dose selector member 35 may also differ in the position of the maximum stop feature 35c. The dose sleeves 38 are mechanically identical between the individual variants but differ in appearance due to different positions and / or numbering of their optical markers. The caps 1 are identical in shape but differ in their appearance, such as colors and / or labeling. According to other embodiments, the caps 1 may also be configured as mutual members.

[0318] The interoperability of the further drug delivery device 10 variant may then be all other elements of the administration mechanism 30.

[0319] According to both types of drug delivery devices 10, 200, the mechanical advantage of the dosing mechanism 230 during dose dispensing may differ between the devices of the individual sets. For example, a set may include one device having a higher mechanical advantage than another device of the respective set. Among these devices, the driver 41, 350 and the parts of the housing 210 that are threadably connected to the driver 41, 350, such as the inner housing 180 and the piston guide 43, may be mechanically different from each other due to the different pitches of their threads 67, 186, 353. Additionally or alternatively, the dosing member 330, in particular the dose sleeve 38, and the parts of the housing 210 that are threadably connected to the dosing member 330, such as the inner housing 180 and the housing 3, may be mechanically different from each other due to the different pitches of their threads 39, 185, 335. All sets of drug delivery devices 10, 200 described in this disclosure may include drug delivery devices 10, 200 that differ in the mechanical advantage of their dosing mechanism 230 during dose dispensing.

[0320] Figures 44 and 45 show alternative embodiments of the reset element 110 of the drug delivery device 200. Unless differences are stated or apparent from the figures, the reset element 110 according to the alternative embodiments is then configured as disclosed in relation to the reset element 110 of the drug delivery device 200, and vice versa.

[0321] The reset element 110 includes guide structures 116 located within the cartridge cavity 115. The guide structures 116 have an elongated shape and extend parallel to the longitudinal axis 207. The guide structures 116 are disposed on circumferential sidewalls of the cartridge cavity 115. Thus, the guide structures 116 are equally spaced apart from one another. According to the embodiment shown in FIGS. 44 and 45, the reset element 110 illustratively includes eight guide structures 116. According to other embodiments, the reset element 110 may include more or fewer guide structures 116.

[0322] The guiding structures 116 are configured to center the distal end of the cartridge 8 relative to the longitudinal axis 207 when the dispensing unit 410 is attached to the drug delivery device 200. The guiding structures 116 radially touch the cartridge 8 inserted into the cartridge holder 412. Thus, they only define the lateral position of the cartridge 8 relative to the longitudinal axis 207, but not the axial position of the distal end of the cartridge 8. Moreover, the axial position of the distal end of the cartridge 8 also does not define the axial position of the reset element 110.

[0323] The guiding structure 116 is configured to not be pushed by the cartridge 8 during attachment of the dispensing unit 410 to the drug delivery device 200. The guiding structure 116 includes an inclined front surface 116a facing in a proximal direction. The inclined front surface 116a centers the cartridge 8 but prevents the reset element 110 from receiving an axial force via the cartridge 8 that would axially displace the reset element 110. The guiding structure 116 also includes an inclined rear surface 116b facing in a distal direction.

[0324] Both the front surface 116a and the rear surface 116b may have an angle with the longitudinal axis 207 that is up to 45°, e.g., up to 30°, 20°, or 10°. For example, the front surface 116a may have an angle with the longitudinal axis 207 that is greater than 5°, greater than 10°, or greater than 15°, and / or less than 45°, less than 30°, or less than 25°. The angle may be, for example, equal to 20°. The rear surface 116b may have an angle with the longitudinal axis 207 that is, for example, greater than 0° or greater than 0.5°, and / or less than 10°, less than 5°, or less than 2.5°. The angle may be, for example, equal to 1°.

[0325] 46 shows an alternative embodiment of the coupling portion 130 of the drug delivery device 200. Unless differences are stated or apparent from the figure, the coupling portion 130 according to the alternative embodiment is then configured as disclosed in relation to the coupling portion 130 of the drug delivery device 200, and vice versa.

[0326] An alternative embodiment of the coupling portion 130 includes four protrusions 138. The protrusions 138 are circumferentially distributed about the longitudinal axis 207 and are equally spaced circumferentially from one another.

[0327] Furthermore, an alternative embodiment of the coupling portion 130 includes recesses 139a in addition to the slots 139. In FIG. 46, the coupling portion 130 is illustratively shown with two recesses 139a. The recesses 139a are located at a distal end of the coupling portion 130. Each recess 139a is centered with one of the first locking structures 137 and divides the respective first locking structure 137 into two portions. As can be further seen from FIG. 46, the slots 139 and recesses 139a are alternately distributed in the circumferential direction and are equally spaced apart from each other.

[0328] 47 shows an alternative embodiment of the reset element 110 and an alternative embodiment of the coupling portion 130 mounted to an alternative embodiment of the inner housing 180. Unless differences are stated or apparent from the figures, the alternative embodiment of the housing 180 is configured as described above in relation to the inner housing 180 of the drug delivery device 200, and vice versa.

[0329] The alternative embodiment of the inner housing 180 includes one of the tappets 184 for each of the slots 139 and recesses 139a. Thus, generally, the inner housing 180 includes four tappets 184. The tappets 184 are provided at a proximal end of the inner housing 180. Furthermore, the tappets are equally spaced apart from one another circumferentially about the longitudinal axis 207.

[0330] Figures 48-49 show alternative connections between alternative embodiments of the inner housing 180 and alternative embodiments of the dose selector member 310. Unless differences are stated or apparent from the figures, the alternative embodiments of the inner housing 180 and / or the alternative embodiments of the dose selector member 310 are configured as described above in relation to the other embodiments of the inner housing 180 and dose selector member 310 according to the present disclosure.

[0331] The dose selector member 310 shown in Figures 48 and 49 comprises longitudinal protrusions 319a on two flexible members 319 which protrude radially outwardly into longitudinal slots 198 in the inner housing 180. As can be seen in Figure 48, the longitudinal slots 198 receiving the protrusions 319a have recesses 193 at their distal ends. The recesses 193 of each slot 198 are configured to receive the protrusions 319a located in the respective slots 198 when the dose selector member 310 is fully extended in the distal direction from the inner housing 180, for example following the setting of the maximum settable dose. This is further illustrated in Figure 50, which shows the inner housing 180, dose selector member 310 and dispensing member 330 with no dose set, and in Figure 51, which shows the inner housing 180, dose selector member 310 and dispensing member 330 with the maximum dose set.

[0332] When the maximum dose is set, the stop surface 338 of the maximum dose stop 337 abuts against the limiting surface 192 of the maximum stop feature 190. Furthermore, the radial protrusion 198a is received in the recess 193. According to the embodiment of the drug delivery device 200 shown in Figs. 48-51, the inner housing 180 comprises two maximum stop features 190 located opposite each other with respect to the longitudinal axis 207. Instead of two further maximum stop features 190, the inner housing 180 comprises two longitudinal slots 198 with recesses 193 at their distal ends. The longitudinal slots 198 with recesses 193 are also located opposite each other with respect to the longitudinal axis 207. In the circumferential direction, the inner housing 180 comprises alternating longitudinal slots 198 characterized by limiting surfaces 192 and longitudinal slots 188 characterized by recesses 193.

[0333] The radial projection 319a and the recess 193 may be provided between the dose selector member 310 and the inner housing 180 and serve as a further maximum dose stop mechanism that limits the axial movement of the dosing member 330 and the dose selector member 310 upon the maximum settable dose being set. Alternatively or additionally, the radial projection 319a and the recess 193 may provide a locking means that prevents the dose selector member 310 from being removed from the housing 210 after assembly of the drug delivery device 200. For example, the radial projection 319a and the recess 193 may be configured such that they do not touch each other upon engagement between the stop surface 338 and the limiting surface 192, but only touch upon the dose selector member 310 being forced further in the distal direction. Alternatively, the radial projection 319a and the recess 193 may be configured such that they essentially touch at the same time that the stop surface 338 touches the limiting surface 192.

[0334] As can be seen from Figures 49 and 50, an inner housing 180 configured to receive an alternative embodiment of a dose selector member 310 having radial projections 319a may also have four tappets 183 and may be configured for use in a drug delivery device 200 featuring the alternative embodiment of a coupling portion 130 shown in Figures 46 and 47. Alternatively, such an inner housing 118 may also feature only two tappets 184 and may be configured for use with a coupling portion 130 described in relation to Figures 27-33.

[0335] As can be seen from Figure 51, the dose-regulating mechanism 232 of the drug delivery device 200 having an alternative embodiment of the dose selector member 310 and the inner housing 180 is illustratively configured as described in relation to Figures 36 and 37 for the first drug delivery device 220 configured to eject a maximum dose of 1.8 mg of active pharmaceutical ingredient.

[0336] As described in relation to the first drug delivery device 220, the second drug delivery device 222 and the third drug delivery device 225, the clutch mechanisms 234 of the individual drug delivery devices 220, 222, 225 of each set may define a different number of pivotal coupling positions at which the first part 235 of the clutch mechanism 234 may close to pivotally couple the nut 250 and / or the clutch member 270 to the dosing member 330. These pivotal coupling positions are defined by the circumferential positions of the clutch elements 273, 336.

[0337] The angular spacing of the pivotal coupling positions corresponds to the angular spacing between the dose positions that is settable by pivoting the dose setting member 290. According to a drug delivery device 200 of the type described in relation to Figures 1-37 and 44-51, the angular spacing between the pivotal coupling positions is equal to the angular spacing between the dose positions. Generally, these positions may correspond such that the angular spacing between the dose positions is an integer multiple of the angular spacing between the coupling positions. For example, depending further on the circumferential position of the dose stop 35a on the inner surface of the dose selector member 35 of the drug delivery device 10, the angular spacing between the dose positions defined by the dose stop 35a may be an integer multiple of the pivotal coupling positions defined by the clutch element 34a on the connector 34 and the clutch element 33a on the snap element 33.

[0338] The embodiment of the clutch member 270 of the drug delivery device 200 shown in Figures 16 and 17 comprises one clutch element 273 for each pivotal coupling position. In principle, therefore, a single clutch element 336 on the dosing member 330 is sufficient to define the pivotal coupling positions. According to alternative embodiments of the clutch member 270, the number of clutch elements 273 may also differ from the number of pivotal coupling positions. For example, the number of clutch elements 273 may be smaller than the number of pivotal coupling positions per rotation of the dose setting member 290. Thus, the number of clutch elements 273 may be smaller by at least one, at least two or more clutch elements 273, such as by only one or two.

[0339] The embodiment of the dosing member 330 shown in Fig. 20 comprises one clutch element 336 for each pivotal coupling position. In principle, therefore, a single clutch element 273 on the clutch member 270 is sufficient to define the pivotal coupling positions. According to alternative embodiments of the dosing member 330, the number of clutch elements 336 may also differ from the number of pivotal coupling positions. For example, the number of clutch elements 336 may be smaller than the number of pivotal coupling positions per rotation of the dose setting member 290. Thus, the number of clutch elements 336 may be smaller by at least one, by at least two or by more clutch elements 336, such as by only one or two.

[0340] 52 illustrates an alternative embodiment of the clutch member 270 of the drug delivery device 200. Unless differences are noted or apparent from the figures, the alternative embodiment of the clutch member 270 is configured as disclosed in connection with the clutch member 270 described above.

[0341] The number of clutch elements 273 in the alternative embodiment of the clutch member 270 is two less than the number of pivotal coupling positions. The clutch elements 273 are located next to each other in two groups, each group including the same number of clutch elements 273, i.e., illustratively, eight clutch elements 273, and the clutch elements 273 of each group are equally spaced apart from each other. In the gap between the two groups, a ninth clutch element 273 is missing. The two groups of clutch elements 273 are circumferentially spaced apart from each other by twice the distance between the clutch elements 273 of the individual groups.

[0342] The drug delivery device 10, 200, 220, 222, 225 according to the present disclosure may include a counterweight that may be offset from the longitudinal axis 207 of the device 10, 200, 220, 222, 225 such that the location of the center of gravity of the device 10, 200, 220, 222, 225 is shifted from the longitudinal axis 207 toward the outer shell of the device 10, 200, 220, 222, 225. This prevents the device 10, 200, 220, 222, 225 from rolling when the device 10, 200, 220, 222, 225 is placed on a flat surface.

[0343] Fig. 53 shows a perspective view of a drug delivery device 200 equipped with such a counterweight 160 and without the outer housing 211, and Fig. 54 shows a radial section perpendicular to the longitudinal axis 207 through the device 200 and the counterweight 160. The counterweight 160 is located within the housing 210 of the device 200, i.e. within the outer housing 211. The counterweight is thus disposed between the inner housing 180 and the outer housing 211, and between the dosing mechanism 230 and the outer housing 211.

[0344] The counterweight 160 is disposed on the outer surface 199 of the inner housing 180. The counterweight has a curved bottom surface 161 that faces the longitudinal axis 207 and a curved top surface 162 that faces outwardly from the longitudinal axis 207. The bottom surface 161 forms a segment of a cylindrical shell having a pivot axis that coincides with the longitudinal axis 207. Similarly, the top surface 162 forms a segment of a cylindrical shell having a pivot axis that coincides with the longitudinal axis 207. The bottom surface 161 and the top surface 162 are oriented parallel to one another.

[0345] The counterweight 160 is formed on the outer surface 199 of the inner housing 180, in particular in a seat 170 depicted in FIG. 55. The seat 170 carries the counterweight 160 and comprises a support surface 175 against which the bottom surface 161 of the counterweight 160 rests. The support surface 175 is formed by the outer surface 199 of the inner housing 180. Furthermore, the seat 170 comprises at least one, i.e. two, first longitudinal stop elements 171 that delimit the seat 170 towards the proximal end 205 and a second longitudinal stop element 173 that delimits the seat 170 towards the distal end 206. To prevent rotation of the counterweight 160 in the circumferential direction, the seat 170 comprises two circumferential stop elements 172 that limit the seat 170 in the circumferential direction.

[0346] The first longitudinal stop elements 171 are configured as protrusions located on the outer surface 199 of the inner housing 180. The first longitudinal stop elements 171 are circumferentially spaced apart from one another and located at the same axial position along the longitudinal axis 207. The first longitudinal stop elements 171 have an elongated shape that is oriented perpendicular to the longitudinal axis 207.

[0347] The second longitudinal stop element 173 is configured as a protrusion forming a step in the outer surface 199 of the inner housing 180. The second longitudinal stop element 173 extends perpendicular to the longitudinal axis 207 and forms a radial surface that is oriented perpendicular to the longitudinal axis 207.

[0348] The circumferential stop elements 172 are configured as individual protrusions located on the outer surface 199 of the inner housing 180. The circumferential stop elements are disposed at a distal end of the seat 170. Additionally, the circumferential stop elements are configured as protrusions extending proximally from a second longitudinal stop element 173. The longitudinal stop elements 172 have an elongated shape oriented parallel to the longitudinal axis 207.

[0349] As can be seen in Fig. 54, the seat is covered by the outer housing 211. The counterweight 160 is arranged so that its upper surface 162 abuts against the inner surface of the outer housing 211. The counterweight 160 is sandwiched between the inner housing 180 and the outer housing 211. The covered seat 170 forms a cavity into which the counterweight 160 is inserted. Thus, the counterweight 160 is only held in place by the stop elements 171, 172, 173, the support surface 175 and the inner surface of the outer housing 211.

[0350] 54 , the counterweight 160 causes the center of gravity 208 of the drug delivery device 200 to be located outwardly from the longitudinal axis 207 of the device 200 towards the counterweight 160. The center of gravity 208 is located between the longitudinal axis 207 and the counterweight 160. Furthermore, the distance between the counterweight 160 and the center of gravity 208 is less than the distance between the center of gravity 208 and the longitudinal axis 207.

[0351] The counterweight 160 and the window in the housing 210, illustratively formed by window 211a in the outer housing 211 and window 180a in the inner housing 180, are located at different angular positions relative to the longitudinal axis 207. In the illustrative embodiment of FIG. 54, the counterweight 160 and the window in the housing 210 are located at angular positions that differ by 180°, and thus correspond to opposite sides of the longitudinal axis 207.

[0352] The contact surface of the drug delivery device 200 with the removed cap 209 includes all surface elements of the drug delivery device 200 that touch a flat surface when the drug delivery device 200 rolls without the cap 209 on the surface. According to the drug delivery device 200, the contact surface has a cylindrical outer surface that lacks protrusions that would inhibit the rolling of the housing 210 when placed on the flat surface. Due to the counterweight 160, the drug delivery device 200 rotates on the flat surface until it assumes a stable position and the center of gravity 280 is located between the surface and the longitudinal axis 207.

[0353] In the stable position, the window in the housing 210 is located on the upper side of the drug delivery device 200, facing away from the surface on which the drug delivery device 200 is placed. According to other embodiments of the device 200 and other arrangements of the counterweight 160, the window may also be located on another side of the drug delivery device 200, e.g., on a lateral side.

[0354] 56 shows a perspective view of the counterweight 160. The counterweight is constructed as a metal portion and has a higher density than the plastic portions of the dosing mechanism 230 and the inner housing 180.

[0355] The counterweight 160 is curved around the longitudinal axis 207 of the drug delivery device 200. The counterweight is symmetric about its central plane, which is oriented perpendicular to the longitudinal axis 207.

[0356] The counterweight 160 has a first protrusion 163 on one longitudinal end face and a second protrusion 165 on the opposite longitudinal end face. When inserted in the seat 170, one of the protrusions 163, 165 as shown in FIG. 56, for example the first protrusion 163, is arranged as a proximal protrusion between the first longitudinal stop elements 171. The two front faces 164 of the counterweight 160, which extend radially from the proximal protrusion and are set back along the longitudinal axis 207 relative to the proximal protrusion, are configured to abut the first longitudinal stop element 171. The other of the protrusions 163, 165 shown in FIG. 56, for example the second protrusion 165, is then configured to abut the second longitudinal stop element 173 as a distal protrusion. The width of the counterweight 160 perpendicular to the longitudinal axis 207 is adapted to enable the counterweight 162 to be disposed between the circumferential stop elements 172 .

[0357] According to other embodiments, the distance between the counterweight 160 and the center of gravity 208 may also be less than the distance between the center of gravity 208 and the longitudinal axis 207, as can be seen in FIG. 57, which shows a radial cross section perpendicular to the longitudinal axis 207 through an alternative embodiment of the drug delivery device 200 having the counterweight 160. Locating the center of gravity 208 closer to the longitudinal axis 207 than the counterweight 160 allows for the use of a relatively small counterweight 160 while still shifting the center of gravity outward from the longitudinal axis 207.

[0358] The cross-sectional views of Figures 54 and 57 only show the radial position of the center of gravity 208 in a schematic manner. According to the drug delivery device 200, the longitudinal position of the center of gravity 208 may not be located in the cross-sections depicted in Figures 54 and 57, but may be located in other cross-sections. The longitudinal position of the center of gravity 208 may be, for example, located distally from the longitudinal center of the window 211a in the outer housing 211 along the longitudinal axis 207, or may be located proximally from the longitudinal center of the window 211a in the outer housing 211 along the longitudinal axis 207.

[0359] The present disclosure is also generally directed to dose regulation mechanisms 232 of the drug delivery devices 10, 200, 220, 222, 225. The structure and details of these dose regulation mechanisms 232 are independent of other structural details of the drug delivery devices 10, 200, 220, 222, 225, such as the friction reduction mechanisms 370, 380, the maximum and / or minimum dose stops 35a, 35b, 35c, the connecting means 414, 424, 434, 444, 510, 511, 520, 530, the reset mechanism 100 or the counterweight 160. For example, the present disclosure is directed to the following embodiments:

[0360] 1. A drug delivery device (10, 200, 220, 222, 225) for expelling a user-settable dose, comprising: A housing (3, 43, 210, 221, 223, 226), a dose selector member (35, 310) pivotally fixed to the housing (3, 43, 210, 221, 223, 226) at least during dose setting and axially movable relative to the housing (3, 43, 210, 221, 223, 226); A dispensing member (330); Dose-regulating mechanisms (232) having the dosing member (330) is configured to rotate relative to the dose selector member (35, 310) to vary the set dose; A drug delivery device (10, 200, 220, 222, 225), wherein the dose defining mechanism (232) is configured to define discrete relative rotational positions of the dosing member (330) and the dose selector member (35, 310) which correspond to settable doses of the device.

[0361] 2. A drug delivery device (10, 200, 220, 222, 225) as described in embodiment 1, wherein the dosing member (330) is rotatably and axially movable relative to the housing (3, 43, 210, 221, 223, 226) at least during dose setting.

[0362] 3. A drug delivery device (10, 200, 220, 222, 225) as described in embodiment 1 or 2, wherein the axial distance (x) that the dosing member (330) travels from the zero dose position of the dosing member during dose setting is proportional to the set dose.

[0363] 4. A drug delivery device (10, 200, 220, 222, 225) according to at least one of embodiments 1 to 3, wherein the dosing member (330) is configured to perform at least one complete rotation during dose setting.

[0364] 5. A drug delivery device (10, 200, 220, 222, 225) according to at least one of embodiments 1 to 4, wherein the dosing member (330), together with the dose selector member (35, 310), is configured to be axially movable relative to the housing (3, 43, 210, 221, 223, 226) during dose setting.

[0365] 6. A drug delivery device (10, 200, 220, 222, 225) according to at least one of embodiments 1 to 5, wherein the administration member (330) is threadably coupled to the housing (3, 43, 210, 221, 223, 226).

[0366] 7. A drug delivery device (10, 200, 220, 222, 225) according to at least one of embodiments 1 to 6, wherein the dose setting mechanism (232) is realized by interaction between two members of the drug delivery device (10, 200, 220, 222, 225) which rotate relative to each other in response to a change in the set dose during dose setting.

[0367] 8. A drug delivery device (10, 200, 220, 222, 225) as described in embodiment 7, wherein the two members interact by an elastic element (33c, 33d, 292) of one of the two members riding on at least one rigid element (35a, 312), such as a dose stop (35a), of the other of the two members.

[0368] 9. The drug delivery device (10, 200, 220, 222, 225) according to one of embodiments 7 and 8, wherein the interaction is inhibited during dose delivery.

[0369] 10. A drug delivery device as described in embodiment 9 (10, 200, 220, 222, 225), wherein the interaction is inhibited during dose delivery by preventing relative rotation of the two members.

[0370] 11. A dose setting member (31, 290) operable by a user to set a dose; A drug delivery device (10, 200, 220, 222, 225) according to at least one of embodiments 1 to 10, wherein the dose-regulating mechanism (232) acts between the dose-setting member (31, 290) and the dose selector member (35, 310).

[0371] 12. A drug delivery device (10, 200, 220, 222, 225) as described in embodiment 11, wherein the dose setting member (31, 290) is configured to be axially movable together with the dose selector member (35, 310) during dose setting.

[0372] 13. A drug delivery device (10, 200, 220, 222, 225) according to at least one of embodiments 11 and 12, wherein the dose setting member (31, 290) is rotatably locked relative to the dose selector member (35, 310) during dose delivery.

[0373] 14. A drug delivery device (10, 200, 220, 222, 225) according to at least one of embodiments 11 to 13, wherein the dose setting member (31, 290) is axially movable relative to the dose selector member (35, 310).

[0374] 15. A drug delivery device (10, 200, 220, 222, 225) according to at least one of embodiments 11 to 14, wherein the dose regulation mechanism (232) is achieved by direct engagement of the dose setting member (31, 290) or a part permanently fixed to the dose setting member (31, 290) together with the dose selector member (35, 310) or a part permanently fixed to the dose selector member (35, 310).

[0375] 16. The dose-measuring mechanism (232) comprises at least one resilient element (33c, 33d, 292) that engages a functional feature (35a, 312), e.g. a dose stop; A drug delivery device (10, 200, 220, 222, 225) according to at least one of embodiments 1 to 15, wherein the circumferential position of the functional feature (35a, 312) around the longitudinal axis (207) of the drug delivery device (10, 200, 220, 222, 225) defines a rotational position of the dosing member (330) corresponding to a settable dose.

[0376] 17. A drug delivery device (10, 200, 220, 222, 225) as described in embodiment 16, wherein the functional features (35a, 312) are located immediately adjacent to each other.

[0377] 18. The drug delivery device (10, 200, 220, 222, 225) according to at least one of embodiments 1 to 17, comprising a clutch mechanism for pivotally coupling the dose selector member (35, 310) and / or the nut of the drug delivery device (10, 200, 220, 222, 225) to the housing (3, 43, 210, 221, 223, 226) during dose delivery.

[0378] 19. A drug delivery device (10, 200, 220, 222, 225) according to embodiment 18 and at least one of embodiments 16 and 17, wherein the clutch mechanism comprises a functional feature (35a, 312).

[0379] 20. The clutch mechanism includes at least one clutch element (294) configured to engage a functional feature (35a, 312) to pivotally couple the dose selector member (35, 310) and / or the nut to the housing (3, 43, 210, 221, 223, 226) during dose delivery; 20. The drug delivery device (10, 200, 220, 222, 225) of embodiment 19, wherein the clutch element (294) is configured separately from the elastic element (33c, 33d, 292).

[0380] 21. A drug delivery device (10, 200, 220, 222, 225) as described in embodiment 20, wherein the clutch element (294) is positioned collinearly with the elastic element (33c, 33d, 292) in a longitudinal direction parallel to the longitudinal axis (207) of the drug delivery device (10, 200, 220, 222, 225).

[0381] 22. A drug delivery device (10, 200, 220, 222, 225) according to at least one of embodiments 16 to 21, wherein the clutch element (294) and / or the functional feature (35a, 312) and / or the elastic element (33c, 33d, 292) have angled flat sides for engaging with each other.

[0382] 23. A drug delivery device (10, 200, 220, 222, 225) according to at least one of embodiments 1 to 22, wherein the dose defining mechanism (232) defines a plurality of equidistant, rotated dose positions.

[0383] 24. A drug delivery device (10, 200, 220, 222, 225) according to at least one of embodiments 1 to 23, wherein the dose selector member (35, 310) surrounds the dosing member (330).

[0384] 25. A drug delivery device (10, 200, 220, 222, 225) as described in at least one of embodiments 1 to 24, wherein none of the rotating parts of the drug delivery device (10, 200, 220, 222, 225) is accessible by a user of the drug delivery device (10, 200, 220, 222, 225) during dose delivery.

[0385] The present disclosure is also generally directed to the connection means 414, 424, 434, 444, 510, 511, 520, 530 of the drug delivery device 10, 200, 220, 222, 225 and / or the dispensing unit 410, 420, 430, 440. The structure and details of these connection means 414, 424, 434, 444, 510, 511, 520, 530 are independent of other structural details of the drug delivery device 10, 200, 220, 222, 225, such as the friction reduction mechanism 370, 380, the maximum and / or minimum dose stops 35a, 35b, 35c, the reset mechanism 100 or the counterweight 160. For example, the present disclosure is directed to the following embodiments:

[0386] 1. A set of two or more drug delivery devices (10, 200, 220, 222, 225), a first drug delivery device (10, 200, 220, 222, 225) having a proximal end with a first keyed connecting means (510, 511, 520, 530); a second drug delivery device (10, 200, 220, 222, 225) having a proximal end with a second keyed connecting means (510, 511, 520, 530); Equipped with The first keyed connecting means (510, 511, 520, 530) of the first drug delivery device (10, 200, 220, 222, 225) is configured to engage with the first keyed connecting means (414, 424, 434, 444) of the first dispensing unit (410, 420, 430, 440) and form a connection with the first keyed connecting means (414, 424, 434, 444), and the second drug delivery device (10, the second keyed connection means (510, 511, 520, 530) of the first distribution unit (200, 220, 222, 225) is configured to engage with a second keyed connection means (414, 424, 434, 444) of a second distribution unit (410, 420, 430, 440) different from the first distribution unit (410, 420, 430, 440) and form a connection with the second keyed connection means (414, 424, 434, 444); The first keyed connecting means (510, 511, 520, 530) of the first drug delivery device (10, 200, 220, 222, 225) is configured not to form a connection with the second keyed connecting means (414, 424, 434, 444) of the second dispensing unit (410, 420, 430, 440), and the second keyed connecting means (510, 511, 520, 530) of the second drug delivery device (10, 200, 220, 222, 225) is configured not to form a connection with the first keyed connecting means (414, 424, 434, 444) of the first dispensing unit (410, 420, 430, 440), set.

[0387] 2. The set of embodiment 1, wherein the keyed connecting means (510, 511, 520, 530) of the drug delivery device (10, 200, 220, 222, 225) each comprises, e.g. consists of, a thread form.

[0388] 3. The set according to embodiment 2, wherein the keyed connecting means (510, 511, 520, 530) of the drug delivery device (10, 200, 220, 222, 225) each comprises an external thread form.

[0389] 4. A set according to one of embodiments 2 and 3, wherein the thread forms of the keyed connecting means (510, 511, 520, 530) of the drug delivery device (10, 200, 220, 222, 225) each have the same core diameter (CD1, CD2, CD3).

[0390] 5. A set according to any one of embodiments 2 to 4, wherein the thread forms of the keyed connecting means (510, 511, 520, 530) of the drug delivery device (10, 200, 220, 222, 225) each have a different outer diameter (D1, D2, D3).

[0391] 6. The set according to any one of embodiments 2 to 5, wherein the thread forms of the keyed connecting means (510, 511, 520, 530) of the drug delivery device (10, 200, 220, 222, 225) are of the same rotational direction.

[0392] 7. The set according to any one of embodiments 2 to 6, wherein the thread forms of the keyed connecting means (510, 511, 520, 530) of the drug delivery device (10, 200, 220, 222, 225) differ in at least one thread dimension, such as outer diameter (D1, D2, D3) and / or thread width (w1, w2, w3) and / or thread height (h1, h2, h3) and / or pitch (P1, P2, P3) and / or core diameter (CD1, CD2, CD3) and / or opening angle (A1, A2, A3).

[0393] 8. The set according to any one of embodiments 2 to 7, wherein the thread forms of the keyed connecting means (510, 511, 520, 530) of the drug delivery device (10, 200, 220, 222, 225) each have the same pitch (P1, P2, P3).

[0394] 9. The set according to any one of embodiments 2 to 8, wherein the thread forms of the keyed connecting means (510, 511, 520, 530) of the drug delivery device (10, 200, 220, 222, 225) each have a different thread width (w1, w2, w3).

[0395] 10. The set according to embodiment 9, wherein the thread width (w2, w3) of the keyed connecting means (520, 530) of the second drug delivery device (222, 225) is larger than the thread width (w1) of the keyed connecting means (511) of the first drug delivery device (220), for example, two or three times larger.

[0396] 11. The set according to any one of embodiments 2 to 10, wherein the thread forms of the keyed connecting means (510, 511, 520, 530) of the drug delivery device (10, 200, 220, 222, 225) each have different thread heights (h1, h2, h3).

[0397] 12. The set according to embodiment 11, wherein the thread height (h1) of the keyed connecting means (511) of the first drug delivery device (220) is greater than the thread height (h2, h3) of the keyed connecting means (520, 530) of the second drug delivery device (222, 225), for example by two or three times greater.

[0398] 13. A set according to any one of embodiments 2 to 12, wherein the thread forms of the keyed connecting means (510, 511, 520, 530) of the drug delivery device (10, 200, 220, 222, 225) each have the same opening angle (A1, A2, A3), for example in the amount of 60°.

[0399] 14. A set according to any one of embodiments 1 to 13, wherein the dial rotation resolutions of the drug delivery devices (10, 200, 220, 222, 225) are different or the same from each other.

[0400] 15. A set of two or more distribution units (410, 420, 430, 440), a first dispensing unit (410, 420, 430, 440) having a distal end with a first keyed connecting means (414, 424, 434, 444); a second dispensing unit (410, 420, 430, 440) having a distal end with a second keyed connecting means (414, 424, 434, 444); Equipped with The first keyed connecting means (414, 424, 434, 444) of the first dispensing unit (410, 420, 430, 440) is configured to engage with the first keyed connecting means (510, 511, 520, 530) of the first drug delivery device (10, 200, 220, 222, 225) and form a connection with the first keyed connecting means (510, 511, 520, 530), and the second dispensing unit (410, 420, 430, 440) is configured to engage with the first keyed connecting means (510, 511, 520, 530) of the first drug delivery device (10, 200, 220, 222, 225) and form a connection with the first keyed connecting means (510, 511, 520, 530). the second keyed connecting means (414, 424, 434, 444) of the first drug delivery device (10, 200, 220, 222, 225) is configured to engage with and form a connection with the second keyed connecting means (510, 511, 520, 530) of a second drug delivery device (10, 200, 220, 222, 225) that is different from the first drug delivery device (10, 200, 220, 222, 225); The first keyed connecting means (414, 424, 434, 444) of the first dispensing unit (410, 420, 430, 440) is configured not to form a connection with the second keyed connecting means (510, 511, 520, 530) of the second drug delivery device (10, 200, 220, 222, 225), and the second keyed connecting means (414, 424, 434, 444) of the second dispensing unit (410, 420, 430, 440) is configured not to form a connection with the first keyed connecting means (510, 511, 520, 530) of the first drug delivery device (10, 200, 220, 222, 225), set.

[0401] 16. The set according to embodiment 15, wherein each of the dispensing units (410, 420, 430, 440) has a drug compartment (81) containing a fluid containing a drug, e.g., insulin or HGH.

[0402] 17. The set according to embodiment 16, wherein the fluids in the drug compartments (81) of the dispensing units (410, 420, 430, 440) differ from each other at least in the concentration of the drug.

[0403] 18. The set according to any one of embodiments 15 to 17, wherein each of the distribution units (410, 420, 430, 440) has an open distal end configured to allow axial movement of the piston rod (42, 240) contained within the corresponding drug delivery device (10, 200, 220, 222, 225), such that the piston rod (42, 240) can move beyond the distal end into the distribution unit (410, 420, 430, 440) when attached to the corresponding drug delivery device (10, 200, 220, 222, 225).

[0404] 19. The set according to any one of embodiments 15 to 18, wherein the keyed connecting means (414, 424, 434, 444) of the dispensing units (410, 420, 430, 440) each comprises, e.g. consists of, a thread form.

[0405] 20. The set according to embodiment 19, wherein the keyed connecting means (414, 424, 434, 444) of the dispensing units (410, 420, 430, 440) each comprise an internal thread form.

[0406] 21. The set according to one of embodiments 19 and 20, wherein the thread forms of the keyed connecting means (414, 424, 434, 444) of the distribution units (410, 420, 430, 440) each have the same core diameter (CD1, CD2, CD3).

[0407] 22. The set according to any one of embodiments 19 to 21, wherein the thread forms of the keyed connecting means (414, 424, 434, 444) of the distribution units (410, 420, 430, 440) each have a different outer diameter (D1, D2, D3).

[0408] 23. The set according to any one of embodiments 19 to 22, wherein the thread forms of the keyed connecting means (414, 424, 434, 444) of the distribution units (410, 420, 430, 440) are of the same rotational direction.

[0409] 24. The set according to any one of embodiments 19 to 23, wherein the thread forms of the keyed connecting means (414, 424, 434, 444) of the distribution units (410, 420, 430, 440) each have the same pitch (P1, P2, P3).

[0410] 25. The set according to any one of embodiments 19 to 24, wherein the thread forms of the keyed connecting means (414, 424, 434, 444) of the dispensing units (410, 420, 430, 440) each have a different thread width (w1, w2, w3).

[0411] 26. The set according to embodiment 25, wherein the thread width (w2, w3) of the keyed connecting means (434, 444) of the second distribution unit (430, 440) is larger than the thread width (w1) of the keyed connecting means (424) of the first distribution unit (420), for example, two or three times larger.

[0412] 27. The set according to any one of embodiments 19 to 26, wherein the thread forms of the keyed connecting means (414, 424, 434, 444) of the dispensing units (410, 420, 430, 440) each have different thread heights (h1, h2, h3).

[0413] 28. The set according to embodiment 27, wherein the thread height (h1) of the keyed connecting means (424) of the first distribution unit (420) is greater than the thread height (h2, h3) of the keyed connecting means (434, 444) of the second distribution unit (430, 440), for example, two or three times greater.

[0414] 29. The set according to any one of embodiments 19 to 28, wherein the thread forms of the keyed connecting means (414, 424, 434, 444) of the distribution units (410, 420, 430, 440) each have an opening angle (A1, A2, A3) in the amount of, for example, 60°.

[0415] 30. The set according to any one of embodiments 15 to 29, wherein at least the keyed connecting means (414, 424, 434, 444) of the dispensing units (410, 420, 430, 440) are formed by injection molding.

[0416] 31. A set of at least one drug delivery device (10, 200, 220, 222, 225) from the set according to any one of embodiments 1 to 14 and at least one dispensing unit (410, 420, 430, 440) from the set according to any one of embodiments 15 to 30, The keyed connecting means (510, 511, 520, 530) of at least one drug delivery device (10, 200, 220, 222, 225) engages with the keyed connecting means (414, 424, 434, 444) of the at least one dispensing unit (410, 420, 430, 440) and forms a connection with the keyed connecting means (414, 424, 434, 444), set.

[0417] 32. A set comprising at least two drug delivery devices (10, 200, 220, 222, 225) from the set according to any one of embodiments 1 to 14 and at least two dispensing units (410, 420, 430, 440) from the set according to any one of embodiments 15 to 30; The set described in embodiment 31, wherein each keyed connection means (510, 511, 520, 530) of the drug delivery device (10, 200, 220, 222, 225) is configured to form a connection only with the connection means (414, 424, 434, 444) of one distinct dispensing unit (410, 420, 430, 440) and not with the connection means (414, 424, 434, 444) of other dispensing units (410, 420, 430, 440).

[0418] The present disclosure is also generally directed to the cartridge holders 2, 412, 422, 432, 432 of the dispensing units 410, 420, 430, 440 of the drug delivery devices 10, 200, 220, 222, 225. The structure and details of these cartridge holders 2, 412, 422, 432, 432 are independent of other structural details of the drug delivery devices 10, 200, 220, 222, 225, such as the friction reduction mechanisms 370, 380, the maximum and / or minimum dose stops 35a, 35b, 35c, the connecting means 414, 424, 434, 444, 510, 511, 520, 530, the reset mechanism 100 or the counterweight 160. For example, the present disclosure is directed to the following embodiments:

[0419] 1. A cartridge holder (2, 412, 422, 432, 432) of a dispensing unit (410, 420, 430, 440) of a drug delivery device (10, 200, 220, 222, 225), comprising: the cartridge holder (2, 412, 422, 432, 432) is configured to receive a cartridge (8) having a drug compartment (81) filled with a drug; The cartridge holder (2, 412, 422, 432, 432) is provided with a locking element (404) configured to non-releasably, e.g., permanently, connect the cartridge to the cartridge holder (2, 412, 422, 432, 432) during use of the dispensing unit (410, 420, 430, 440).

[0420] 2. A cartridge holder (2, 412, 422, 432, 432) as described in embodiment 1, wherein the cartridge holder (2, 412, 422, 432, 432) is provided with a biasing element (406) configured to bias and / or push the cartridge (8) into the cartridge holder (2, 412, 422, 432, 432) after insertion.

[0421] 3. A cartridge holder (2, 412, 422, 432, 432) as described in embodiment 2, wherein the biasing element (406) is configured separately from the locking element (404).

[0422] 4. A cartridge holder (2, 412, 422, 432, 432) as described in embodiment 3, wherein the biasing element (406) and the locking element (404) are located on opposite sides of the cartridge holder (2, 412, 422, 432, 432).

[0423] 5. A cartridge holder (2, 412, 422, 432, 432) according to at least one of embodiments 3 and 4, wherein the biasing element (406) and the locking element (404) are located at the same longitudinal position of the cartridge holder (2, 412, 422, 432, 432).

[0424] 6. A cartridge holder (2, 412, 422, 432, 432) according to at least one of embodiments 3 to 5, wherein both the locking element (404) and the biasing element (406) are configured to act against the same surface (83) of the cartridge holder (8).

[0425] 7. A cartridge holder (2, 412, 422, 432, 432) according to at least one of embodiments 2 to 6, wherein the biasing element (406) is located within a proximal portion of the cartridge holder (2, 412, 422, 432, 432), such as the proximal ½, the proximal ⅓ or the proximal ¼ of the cartridge holder (2, 412, 422, 432, 432).

[0426] 8. A cartridge holder (2, 412, 422, 432, 432) according to at least one of embodiments 2 to 7, wherein the biasing element (406) protrudes radially into the cartridge cavity (413) of the cartridge holder (2, 412, 422, 432, 432).

[0427] 9. A cartridge holder (2, 412, 422, 432, 432) according to any one of embodiments 2 to 8, wherein the biasing element (406) is configured to bend radially outward from the longitudinal axis (207) of the cartridge holder (2, 412, 422, 432, 432) and outward from the cartridge (8) upon an attempt to remove the cartridge (8) from the cartridge holder (412).

[0428] 10. A cartridge holder (2, 412, 422, 432, 432) according to at least one of embodiments 2 to 9, wherein the biasing element (406) is configured to engage with a distal surface (83) of the cartridge (8) facing away from the needle end of the cartridge holder (2, 412, 422, 432, 432) after insertion.

[0429] 11. The cartridge holder (2, 412, 422, 432, 432) according to at least one of embodiments 2 to 10, wherein the biasing element (406) is configured to engage with the annular rim (82) of the cartridge (8).

[0430] 12. A cartridge holder (2, 412, 422, 432, 432) according to at least one of embodiments 2 to 11, wherein the biasing element (406) is configured to permanently contact the cartridge (8) after insertion into the cartridge holder (2, 412, 422, 432, 432).

[0431] 13. A cartridge holder (2, 412, 422, 432, 432) according to at least one of embodiments 2 to 12, wherein the biasing element (406) is configured to bias the cartridge (8) against a stop (408) configured to prevent proximal movement of the cartridge (8).

[0432] 14. A cartridge holder (2, 412, 422, 432, 432) according to at least one of embodiments 2 to 13, wherein the biasing element (406) is configured to clamp the cartridge (8) between the stop portion (408) and the biasing element (406), such that both the stop portion (408) and the biasing element (406) rest against the cartridge (8) simultaneously.

[0433] 15. A cartridge holder (2, 412, 422, 432, 432) according to at least one of embodiments 13 and 14, wherein the stop portion (408) is located at the needle end of the cartridge holder (2, 412, 422, 432, 432).

[0434] 16. A cartridge holder (2, 412, 422, 432, 432) according to at least one of embodiments 2 to 15, wherein the biasing element (406) is configured to bias the cartridge (8) outwardly from the contact surface (405) of the locking element (404).

[0435] 17. The cartridge holder (2, 412, 422, 432, 432) according to at least one of embodiments 2 to 16, wherein the biasing element (406) is configured as an integral part of the cartridge holder (2, 412, 422, 432, 432).

[0436] 18. The cartridge holder (2, 412, 422, 432, 432) according to embodiment 17, wherein the biasing element (406) is configured as a cut-out portion of the cartridge holder (2, 412, 422, 432, 432).

[0437] 19. A cartridge holder (2, 412, 422, 432, 432) according to at least one of embodiments 1 to 18, wherein the locking element (404) is configured to be biased towards the longitudinal axis (207) of the cartridge holder (2, 412, 422, 432, 432) when an attempt is made to remove the cartridge (8) from the cartridge holder (412) and the cartridge (8) engages with the locking element (404).

[0438] 20. A cartridge holder (2, 412, 422, 432, 432) according to at least one of embodiments 1 to 19, wherein the locking element (404) has a contact surface (405) configured to engage with the cartridge (8) to prevent removal of the cartridge (8) from the cartridge holder (2, 412, 422, 432, 432).

[0439] 21. A cartridge holder (2, 412, 422, 432, 432) as described in embodiment 20, wherein the contact surface (405) is angled with respect to the longitudinal axis (207) of the cartridge holder (2, 412, 422, 432, 432) and faces the proximal end of the cartridge holder (2, 412, 422, 432, 432).

[0440] 22. A cartridge holder (2, 412, 422, 432, 432) according to at least one of embodiments 19 and 21, wherein the contact surface (405) is oriented perpendicular to the longitudinal axis (207) of the cartridge holder (2, 412, 422, 432, 432).

[0441] 23. A cartridge holder (2, 412, 422, 432, 432) according to at least one of embodiments 19 to 22, wherein the contact surface (405) is located outward from the cartridge (8) after the cartridge (8) is fully inserted into the cartridge holder (2, 412, 422, 432, 432).

[0442] 24. A cartridge holder (2, 412, 422, 432, 432) according to at least one of embodiments 1 to 23, wherein the locking element (404) is configured to engage with a distal surface (83) of the cartridge (8) facing away from the needle end of the cartridge holder (2, 412, 422, 432, 432) after insertion.

[0443] 25. The cartridge holder (2, 412, 422, 432, 432) according to at least one of embodiments 1 to 24, wherein the locking element (404) is configured to engage with the annular rim (82) of the cartridge (8).

[0444] 26. The cartridge holder (2, 412, 422, 432, 432) according to at least one of the preceding embodiments, wherein the locking element (404) is designed as a snap-fit ​​connection, for example as a snap hook.

[0445] 27. The cartridge holder (2, 412, 422, 432, 432) according to at least one of the preceding embodiments, wherein the locking element (404) is configured as an integral part of the cartridge holder (2, 412, 422, 432, 432).

[0446] 28. A cartridge holder (2, 412, 422, 432, 432) according to embodiment 27, wherein the locking element (404) is configured as a cut-out portion of the cartridge holder (2, 412, 422, 432, 432).

[0447] 29. A cartridge holder (2, 412, 422, 432, 432) according to at least one of embodiments 1 to 28, wherein the locking element (404) is located within a proximal portion of the cartridge holder (2, 412, 422, 432, 432), such as the proximal ½, the proximal ⅓ or the proximal ¼ of the cartridge holder (2, 412, 422, 432, 432).

[0448] 30. A cartridge holder (2, 412, 422, 432, 432) according to at least one of embodiments 1 to 29, wherein the locking element (404) protrudes radially into the cartridge cavity (413) of the cartridge holder (2, 412, 422, 432, 432).

[0449] 31. A cartridge holder (2, 412, 422, 432, 432) according to at least one of embodiments 1 to 30, wherein the cartridge holder (2, 412, 422, 432, 432) is provided with connection means (414, 424, 434, 444) configured to connect to corresponding connection means (510, 511, 520, 530) of the drug delivery device (10, 200, 220, 222, 225) for releasably connecting the cartridge holder (2, 412, 422, 432, 432) with the drug delivery device (10, 200, 220, 222, 225).

[0450] 32. A set of at least a first cartridge holder (2, 412, 422, 432, 432) according to embodiment 31 and at least a second cartridge holder (2, 412, 422, 432, 432) according to embodiment 31, the connecting means (414, 424, 434, 444) of the first cartridge holder (2, 412, 422, 432, 432) and the second cartridge holder (2, 412, 422, 432, 432) are configured as keyed connecting means; The connection means (414, 424, 434, 444) of the first cartridge holder (2, 412, 422, 432, 432) are configured to engage with the connection means (510, 511, 520, 530) of the first drug delivery device (10, 200, 220, 222, 225) and form a connection with the connection means (510, 511, 520, 530) of the second cartridge holder (2, 412 the connecting means (414, 424, 434, 444) of the first drug delivery device (10, 200, 220, 222, 225) are configured to engage with the connecting means (510, 511, 520, 530) of a second drug delivery device (10, 200, 220, 222, 225) different from the first drug delivery device (10, 200, 220, 222, 225) and form a connection with the connecting means (510, 511, 520, 530); The connection means (414, 424, 434, 444) of the first cartridge holder (2, 412, 422, 432, 432) are configured not to form a connection with the connection means (510, 511, 520, 530) of the second drug delivery device (10, 200, 220, 222, 225), and the connection means (414, 424, 434, 444) of the second cartridge holder (2, 412, 422, 432, 432) are configured not to form a connection with the connection means (510, 511, 520, 530) of the first drug delivery device (10, 200, 220, 222, 225), set.

[0451] 33. A set of a cartridge holder (2, 412, 422, 432, 432) according to at least one of the preceding embodiments and a cartridge (8) containing a drug, A cartridge (8) is inserted into a cartridge holder (2, 412, 422, 432, 432) and non-releasably held within the cartridge holder (2, 412, 422, 432, 432).

[0452] The drug delivery device according to the present disclosure is further characterized by the embodiments listed below.

[0453] 1. A drug delivery device (10, 200, 220, 222, 225) comprising: a housing (3, 43, 210, 221, 223, 226) having a longitudinal axis (207); a dose setting member (31, 290) actuatable by a user and rotatable about a longitudinal axis (207) to set a dose delivered by the drug delivery device (10, 200, 220, 222, 225); a piston rod (42, 240) configured to be advanced axially, e.g., proximally outwardly from the housing (3, 43, 210, 221, 223, 226), to deliver a set dose; a dosing member (330) for defining the axial advancement of the piston rod (42, 240) during delivery of a set dose; the dosing member (330) is axially movable along the longitudinal axis (207) during dose setting and is pivotally movable about the longitudinal axis (207); the dosing member (330) is pivotally fixed to the dose setting member (31, 290) during dose setting; The dispensing member (330) is provided with a maximum dose stop (337); the maximum dose stop (337) is configured to engage with the maximum stop feature (190) to limit movement of the dispensing member (330) relative to the housing (3, 43, 210, 221, 223, 226) when the maximum dose is set; A drug delivery device (10, 200, 220, 222, 225), wherein the maximum stop feature (190) is provided on the housing (3, 43, 210, 221, 223, 226).

[0454] 2. A drug delivery device (10, 200, 220, 222, 225) as described in embodiment 1, wherein the dosing member (330) is pivotable relative to the dose setting member (31, 290) during dose delivery.

[0455] 3. the dosing member (330) is configured to perform more than one complete rotation relative to the housing (3, 43, 210, 221, 223, 226) during dose setting, e.g. at least two complete rotations; For example, a drug delivery device (10, 200, 220, 222, 225) according to embodiment 1 or 2, wherein the dosing member (330) is configured to perform two complete rotations to set the maximum settable dose.

[0456] 4. A drug delivery device (10, 200, 220, 222, 225) according to one of embodiments 1 to 3, wherein the dosing member (330) is threadably connected to the housing (3, 43, 210, 221, 223, 226), for example, via an external thread (335) provided on the dosing member (330) and a corresponding internal thread (185) provided on the housing (3, 43, 210, 221, 223, 226).

[0457] 5. A drug delivery device (10, 200, 220, 222, 225) according to one of embodiments 1 to 4, wherein the dosing member (330) is rotatable relative to the housing (3, 43, 210, 221, 223, 226) during both dose setting and dose delivery.

[0458] 6. A drug delivery device (10, 200, 220, 222, 225) according to one of embodiments 1 to 5, wherein the maximum dose stop portion (337) comprises a stop surface (338) configured to axially abut against the maximum stop feature portion (190) of the housing (3, 43, 210, 221, 223, 226) when the maximum dose is set.

[0459] 7. The drug delivery device (10, 200, 220, 222, 225) of embodiment 6, wherein the stop surface (338) is oriented perpendicular to the longitudinal axis (207).

[0460] 8. A drug delivery device (10, 200, 220, 222, 225) according to one of embodiments 6 and 7, wherein the stop surface (338) is an annular surface surrounding the longitudinal axis (207).

[0461] 9. A maximum dose stop (337) protrudes from the outer surface of the dispensing member (330); and / or A drug delivery device (10, 200, 220, 222, 225) according to one of embodiments 1 to 8, wherein the maximum stop feature (190) protrudes from an inner surface of the housing (3, 43, 210, 221, 223, 226).

[0462] 10. A drug delivery device (10, 200, 220, 222, 225) according to one of embodiments 1 to 9, wherein the maximum dose stop (337) is spaced from the distal end of the dosing member (330).

[0463] 11. The maximum stop feature (190) of the housing (3, 43, 210, 221, 223, 226) has a limiting surface (192) that is oriented perpendicular to the longitudinal axis (207); A drug delivery device (10, 200, 220, 222, 225) according to one of the previous embodiments, wherein the maximum dose stop (337) engages with the limiting surface (192) when the maximum dose is set.

[0464] 12. A drug delivery device (10, 200, 220, 222, 225) according to one of embodiments 1 to 11, wherein the maximum stop feature (190) of the housing (3, 43, 210, 221, 223, 226) is provided on a flexible element (191) configured to snap-fit ​​over the maximum dose stop (337) of the dosing member (330) upon assembly of the drug delivery device (10, 200, 220, 222, 225).

[0465] 13. A drug delivery device (10, 200, 220, 222, 225) as described in embodiment 12, wherein the flexible element (191) rests against a backing element, such as an outer housing (211) surrounding the inner housing (180) having the flexible element (191), to prevent the maximum stop feature (190) from disengaging from the maximum dose stop (337) after assembly of the drug delivery device (10, 200, 220, 222, 225).

[0466] 14. A drug delivery device (10, 200, 220, 222, 225) according to one of embodiments 1 to 13, wherein the dosing member (330) is configured as a dose indicating member that provides a visual indication of the set dose to the user, for example via a corresponding optical marker (40, 331) on the outer surface of the dosing member (330).

[0467] 15. A drug delivery device (10, 200, 220, 222, 225) according to one of embodiments 1 to 14, wherein the dose setting member (31, 290) is configured to move axially relative to the housing (3, 43, 210, 221, 223, 226) together with the dosing member (330) during dose setting.

[0468] 16. The dispensing member (330) is provided with a zero dose stop (340); the zero dose stop (340) is configured to engage with the zero stop feature (196) to limit movement of the dispensing member (330) relative to the housing (3, 43, 210, 221, 223, 226) when the dispensing member (330) reaches a zero dose position; A drug delivery device (10, 200, 220, 222, 225) according to one of embodiments 1 to 15, wherein the zero stop feature (196) is provided on the housing (3, 43, 210, 221, 223, 226). Embodiment

[0469] 17. The zero dose stop (340) engages the zero stop feature (196) in a contact plane that is angled relative to a radial plane perpendicular to the longitudinal axis (207); For example, a drug delivery device (10, 200, 220, 222, 225) as described in embodiment 16, wherein the contact plane is oriented perpendicular to the radial plane.

[0470] 18. A drug delivery device (10, 200, 220, 222, 225) according to one of embodiments 16 and 17, wherein the zero dose stop (340) of the dosing member (330) comprises a stop surface configured to abut against a corresponding stop surface of the housing (3, 43, 210, 221, 223, 226).

[0471] 19. A zero dose stop (340) is provided at the proximal end of the dispensing member (330); and / or A drug delivery device (10, 200, 220, 222, 225) according to one of embodiments 16 to 18, wherein the zero stop feature (196) is provided at the proximal end of the housing cavity (189) of the housing (3, 43, 210, 221, 223, 226).

[0472] 20. A drug delivery device (10, 200, 220, 222, 225) according to one of embodiments 16 to 19, wherein the zero stop feature (196) and the maximum stop feature (190) are provided on the same structural element of the housing (3, 43, 210, 221, 223, 226), for example on the inner housing (180).

[0473] 21. A drug delivery device (10, 200, 220, 222, 225) as described in embodiment 20, wherein the structural element comprises a dosage thread (185) that threadably engages with the dosing member (330).

[0474] 22. The structural element comprises a drive thread (186) that threadably engages with a driver (41, 350) of a drug delivery device (10, 200, 220, 222, 225); A drug delivery device (10, 200, 220, 222, 225) as described in one of embodiments 20 and 21, wherein the driver (41, 350) is coupled to the piston rod (42, 240) during dose delivery to axially advance the piston rod (42, 240) upon axial movement of the driver (41, 350).

[0475] 23. The drug delivery device (10, 200, 220, 222, 225) comprises a dose setting mechanism (232) for defining a rotational dose position of the dose setting member (31, 290) relative to the housing (3, 43, 210, 221, 223, 226); a dose setting member (31, 290) connected to the housing (3, 43, 210, 221, 223, 226) via a dose selector member (35, 310); the dose selector member (35, 310) is pivotally fixed and axially movable relative to the housing (3, 43, 210, 221, 223, 226); A drug delivery device (10, 200, 220, 222, 225) according to one of embodiments 1 to 22, wherein the dose-regulating mechanism (232) acts between the dose selector member (35, 310) and the dose-setting member (31, 290).

[0476] 24. A drug delivery device (10, 200, 220, 222, 225) as described in embodiment 23, wherein the dose selector member (35, 310) is axially fixed relative to the dosing member (330).

[0477] 25. the dose selector member (35, 310) is connected to the housing (3, 43, 210, 221, 223, 226) via connections (187, 188, 315, 316) that enable the dose selector member (35, 310) to be mounted to the housing (3, 43, 210, 221, 223, 226) only in a rotational orientation that ensures that the dose setting member (31, 290) is set to a dose position upon engagement of the maximum stop feature (190) of the maximum dose stop (337); For example, a drug delivery device (10, 200, 220, 222, 225) according to one of embodiments 23 and 24, wherein the connection (187, 188, 315, 316) allows only a single rotational direction.

[0478] 26. The connections (187, 188, 315, 316) include spline connections that allow axial movement and prevent rotational movement of the dose selector member (35, 310) relative to the housing (3, 43, 210, 221, 223, 226); A drug delivery device (10, 200, 220, 222, 225) as described in embodiment 25, wherein the spline connection includes a set of coding splines, the coding splines having respective dimensions, e.g. width and / or height, that differ from each other.

[0479] 27. A drug delivery device (10, 200, 220, 222, 225) as described in embodiment 26, wherein the spline connection includes a single coding spline (187, 315) that is different from the remaining splines (188, 316) of the connection (187, 188, 315, 316).

[0480] 28. A drug delivery device (10, 200, 220, 222, 225) according to one of embodiments 1 to 27, wherein the dosing member (330) is coupled to the piston rod (42, 240) via an advancing mechanism that converts axial movement of the dosing member (330) during dose delivery into axial advancement of the piston rod (42, 240), such that axial movement of the dosing member (330) during dose delivery advances the piston rod (42, 240) axially in the proximal direction.

[0481] 29. A drug delivery device (10, 200, 220, 222, 225) as described in embodiment 28, wherein the advancement mechanism is configured as a gearing mechanism that reduces the axial movement of the dosing member (330) to a smaller axial advancement of the piston rod (42, 240).

[0482] 30. The piston rod (42, 240) is rotatably fixed to the housing (3, 43, 210, 221, 223, 226), The advancement mechanism includes a nut (36, 250) coupled between the piston rod (42, 240) and the dispensing member (330); The nut (36, 250) is threadably connected to the piston rod (42, 240); During dose setting, the nut (36, 250) is rotatably fixed to the dosing member (330) and rotatable relative to the housing (3, 43, 210, 221, 223, 226); A drug delivery device (10, 200, 220, 222, 225) according to one of embodiments 28 and 29, wherein during dose delivery, the nut (36, 250) is rotatable relative to the dosing member (330) and rotatably fixed relative to the housing (3, 43, 210, 221, 223, 226).

[0483] 31. The advancement mechanism includes a driver (41, 350) coupled between the nut (36, 250) and the dispensing member (330); a driver (41, 350) that is pivotally fixed to the dispensing member (330) and axially movable relative to the dispensing member (330) during both dose setting and dose delivery; The driver (41, 350) is threadably coupled to the housing (3, 43, 210, 221, 223, 226); A drug delivery device (10, 200, 220, 222, 225) as described in embodiment 30, wherein the driver (41, 350) is configured to engage with the nut (36, 250) during dose delivery to axially advance the nut (36, 250) and the piston rod (42, 240) when rotated by the dosing member (330).

[0484] 32. A drug delivery device (10, 200, 220, 222, 225), comprising: a housing (3, 43, 210, 221, 223, 226) having a longitudinal axis (207); a dose setting member (31, 290) actuatable by a user and rotatable about a longitudinal axis (207) to set a dose delivered by the drug delivery device (10, 200, 220, 222, 225); a piston rod (42, 240) configured to be axially advanced proximally to deliver a set dose; a dosing member (330) for defining the axial advancement of the piston rod (42, 240) during delivery of a set dose; the dosing member (330) is axially movable along the longitudinal axis (207) during dose setting and is pivotally movable about the longitudinal axis (207); the dosing member (330) is pivotally fixed to the dose setting member (31, 290) during dose setting; The dispensing member (330) comprises a zero dose stop (340); the zero dose stop (340) is configured to engage the zero stop feature (196) to limit movement of the dispensing member (330) relative to the housing (3, 43, 210, 221, 223, 226) upon setting of the zero dose; A drug delivery device (10, 200, 220, 222, 225), wherein the zero stop feature (196) is provided on the housing (3, 43, 210, 221, 223, 226).

[0485] 33. A drug delivery device (10, 200, 220, 222, 225) as described in embodiment 32, wherein the dosing member (330) is pivotable relative to the dose setting member (31, 290) during dose delivery.

[0486] 34. The zero dose stop (340) engages the zero stop feature (196) in a contact plane that is angled relative to a radial plane perpendicular to the longitudinal axis (207); For example, a drug delivery device (10, 200, 220, 222, 225) according to one of embodiments 32 and 33, wherein the contact plane is oriented perpendicular to the radial plane.

[0487] 35. A drug delivery device (10, 200, 220, 222, 225) according to one of embodiments 32 to 34, wherein the zero dose stop (340) of the dosing member (330) comprises a stop surface configured to abut against a corresponding stop surface of the housing (3, 43, 210, 221, 223, 226).

[0488] 36. A zero dose stop (340) is provided at the proximal end of the dispensing member (330); and / or A drug delivery device (10, 200, 220, 222, 225) according to one of embodiments 32 to 35, wherein the zero stop feature (196) is provided at the proximal end of the housing cavity (189) of the housing (3, 43, 210, 221, 223, 226). [Explanation of symbols]

[0489] 1 Cap 2 Cartridge holder 3 Outer housing 3a Window 4 needles 5 Hub 6 Cannula 8 Cartridges 8a Sealing means 9 Piston 10 Further Drug Delivery Devices 30 Administration Mechanism 31 Dose setting member 32 Clutch parts 32 Ridge 33 Snap Elements 33a Clutch element 33c Flexible Arm 33d protrusion 33f Further protrusions 34 Connector 34a Clutch element 34b Ridge 35 Dose selector member 35a Dose stop section 35b Maximum Stop Feature 35c Minimum Stop Feature 36 Nut 37 Spline Connection 38 Dosage Sleeve 40 Optical Marker 41 Drivers 42 Piston rod 42a Disc 43 Piston guide 60 External Thread 61 Dose button 67 Thread 63 Stopping Features 64 Protrusion 81 Drug Compartment 82 Annular Rim 83 Distal Surface 85 Annular detent 90 Rotational biasing member 100 Reset Mechanism 110 Reset Element 111 Gripping Zone 112 Receptive Area 113 Inside 114 Opening 115 Cartridge Cavity 116 Guidance Structure 116a Front 116b Rear 117 Contact structure 119 Stop part 120 Engagement feature 130 Joint / insert 134 Binding Site 135 Engagement feature 136 Notch 137 First Lock Structure 138 Protrusion 139 Slots 139a recess 140 Second Lock Structure 150 energizing element 160 Counterweight 161 Bottom 162 Top surface 163 Proximal protrusion 164 Front 165 Distal protrusion 170 Seat area 171 Longitudinal stop element 172 Circumferential stop element 173 Longitudinal Stop Element 175 Stopping surface 180 Inner housing 180a Window 181 Proximal part 182 Distal part 183 Inner Sleeve 184 Tappet 185 dose thread 186 Drive Thread 187 Groove 188 Further Groove 189 Housing Cavity 190 Maximum Stop Feature 191 Hook 192 Restrictions 193 Depression 194 Protrusion 195 Bulge 196 Zero Stop Feature 197 Zero Stop Surface 198 Longitudinal Slot 199 Exterior 200 Drug Delivery Devices 205 Proximal end 206 Distal end 207 Longitudinal Axis 208 Center of gravity 209 Cap 210 Housing 211 Outer housing 211a Window 213 Color 214 Detent 216 Detent 218 Groove 220 First drug delivery device 221 First Housing 222 Second Drug Delivery Device 223 Second Housing 225 Third Drug Delivery Device 226 Third Housing 230 Administration Mechanism 232 Dose-regulating mechanisms 234 Clutch Mechanism 235 First Part 236 Second Part 237 Clutch Mechanism 238 First Part 239 Second Part 240 Piston rod 241 Thread 242 Plunger disc 243 Stop feature 244 Disk Connector 250 Nut 251 Proximal part 252 Distal part 253 Proximal protrusion 254 Longitudinal groove 255 Annular Detent 256 threads 270 Clutch parts 271 Longitudinal ridge 273 Clutch element 274 Proximal part 275 Distal part 277 Connections 278 Snap Hook 279 First ridge 280 Second ridge 290 Dose setting member 292 Elastic Elements 294 Clutch element 295 Depression 296 Opening 297 First longitudinal groove 298 Second longitudinal groove 308 Pressing member 310 Dose selector member 311 Distal part 312 Functional Features 314 Contact surface 315 Ridge 316 More ridges 317 Proximal part 318 Connector 319 Flexible Members 319a Protrusion 320 Detent 322 Interior wall 323 Opening 330 Dispensing member 331 Optical Marker 332 Proximal part 333 Distal part 334 Screw connection 335 External Thread 336 Clutch element 337 Maximum dose stop part 338 Stopping surface 340 Zero Dose Stop 341 Groove 343 Connector 344 Circular ridge 346 Distal End Face 350 Driver 351 Proximal part 352 Screw connection 353 Thread 354 connections 356 Flexible Arm 358 Front 359 Distal part 360 Spline 370 First bearing element 371 Distal Disc 372 Holder 373 Proximal Disc 375 Ball 380 Second Bearing Element 402 Needle Connector 404 Connector 405 Contact surface 406 Actuation elements 407 Contact surface 408 Stop part 409 Ridge 410 Distribution Unit 412 Cartridge Holder 413 Cartridge Cavity 414 Connection means 420 First distribution unit 422 First Cartridge Holder 424 First connection means 430 Second distribution unit 432 Second Cartridge Holder 434 Secondary connection means 440 Third Distribution Unit 442 3rd Cartridge Holder 444 Third Connection Means 450 Contact Features 501 Ridge 502 Valley 510 Connection Method 511 First connection means 520 Second connection means 530 Third Connection Means P1 First Pitch w1 First width h1 First height CD1 First core diameter D1 First outer diameter A1 First angle P2 Second Pitch w2 Second width h2 Second height CD2 Second core diameter D2 Second outer diameter A2 Second angle P3 Third Pitch w3 Third width h3 Third height CD3 Third core diameter D3 Third outer diameter A3 Third Angle

Claims

1. A drug delivery device (10, 200, 220, 222, 225) comprising: a housing (3, 43, 210, 221, 223, 226) having a longitudinal axis (207); a dose setting member (31, 290) actuatable by a user and rotatable about said longitudinal axis (207) to set the dose delivered by said drug delivery device (10, 200, 220, 222, 225); a piston rod (42, 240) configured to be axially advanced proximally to deliver the set dose; a dosing member (330) for defining the axial advancement of the piston rod (42, 240) during delivery of the set dose; said dispensing member (330) being axially movable along said longitudinal axis (207) during dose setting and pivotally movable about said longitudinal axis (207); the dispensing member (330) is rotationally fixed relative to the dose setting member (31, 290) during dose setting; said dispensing member (330) is provided with a maximum dose stop (337); the maximum dose stop (337) is configured to engage with a maximum stop feature (190) to limit movement of the dispensing member (330) relative to the housing (3, 43, 210, 221, 223, 226) when a maximum dose is set; the maximum stop feature (190) is provided on the housing (3, 43, 210, 221, 223, 226); the drug delivery device (10, 200, 220, 222, 225) comprises a dose setting mechanism (232) for defining a rotational dose position of the dose setting member (31, 290) relative to the housing (3, 43, 210, 221, 223, 226); the dose setting member (31, 290) is connected to the housing (3, 43, 210, 221, 223, 226) via a dose selector member (35, 310); the dose selector member (35, 310) is rotationally fixed and axially movable relative to the housing (3, 43, 210, 221, 223, 226); the dose selector member (35, 310) is configured to move distally from the housing (3, 43, 210, 221, 223, 226); the dose-measuring mechanism (232) acts between the dose selector member (35, 310) and the dose-setting member (31, 290), or A drug delivery device (10, 200, 220, 222, 225), wherein the dose regulation mechanism (232) acts between the dose selector member (35, 310) and the dispensing member (330).

2. 2. The drug delivery device (10, 200, 220, 222, 225) of claim 1, wherein the dispensing member (330) is pivotally movable relative to the dose setting member (31, 290) during dose delivery.

3. 3. A drug delivery device (10, 200, 220, 222, 225) as described in claim 1 or 2, wherein the administration member (330) is threadably connected to the housing (3, 43, 210, 221, 223, 226) via an external thread (335) provided on the administration member (330) and a corresponding internal thread (185) provided on the housing (3, 43, 210, 221, 223, 226).

4. A drug delivery device (10, 200, 220, 222, 225) as described in claim 1 or 2, wherein the maximum dose stop portion (337) has a stop surface (338) configured to axially abut the maximum stop feature portion (190) of the housing (3, 43, 210, 221, 223, 226) when the maximum dose is set.

5. The drug delivery device (10, 200, 220, 222, 225) of claim 4, wherein the stop surface (338) is oriented perpendicular to the longitudinal axis (207).

6. 5. The drug delivery device of claim 4, wherein the stop surface is an annular surface surrounding the longitudinal axis.

7. 3. A drug delivery device (10, 200, 220, 222, 225) according to claim 1 or 2, wherein the maximum dose stop (337) protrudes from an outer surface of the dosing member (31, 290).

8. The drug delivery device (10, 200, 220, 222, 225) of claim 1 or 2, wherein the maximum stop feature (190) protrudes from an inner surface of the housing (3, 43, 210, 221, 223, 226).

9. 3. The drug delivery device (10, 200, 220, 222, 225) of claim 1 or 2, wherein the maximum dose stop (337) is spaced from the distal end of the dispensing member (330).

10. the maximum stop feature (190) of the housing (3, 43, 210, 221, 223, 226) has a limiting surface (192) oriented perpendicular to the longitudinal axis (207); 3. A drug delivery device (10, 200, 220, 222, 225) according to claim 1 or 2, wherein the maximum dose stop (337) engages with the limiting surface (192) when the maximum dose is set.

11. A drug delivery device (10, 200, 220, 222, 225) as described in claim 1 or 2, wherein the maximum stop feature (190) of the housing (3, 43, 210, 221, 223, 226) is provided on a flexible element (191) configured to snap-fit ​​onto the maximum dose stop portion (337) of the administration member (330) during assembly of the drug delivery device (10, 200, 220, 222, 225).

12. A drug delivery device (10, 200, 220, 222, 225) as described in claim 11, wherein the flexible element (191) rests against a backing element such as an outer housing (211) surrounding an inner housing (180) having the flexible element to prevent the maximum stop feature (190) from disengaging from the maximum dose stop (337) after assembly of the drug delivery device (10, 200, 220, 222, 225).

13. said dispensing member (330) comprising a zero dose stop (340); the zero dose stop (340) is configured to engage with a zero stop feature (196) to limit movement of the dispensing member (330) relative to the housing (3, 43, 210, 221, 223, 226) when the dispensing member (330) reaches a zero dose position; The drug delivery device (10, 200, 220, 222, 225) of claim 1 or 2, wherein the zero stop feature (196) is provided on the housing (3, 43, 210, 221, 223, 226).

14. A drug delivery device (10, 200, 220, 222, 225) as described in claim 13, wherein the zero dose stop portion (340) engages with the zero stop feature portion (196) in a contact plane that is angled with respect to a radial plane perpendicular to the longitudinal axis (207).

15. 15. The drug delivery device (10, 200, 220, 222, 225) of claim 14, wherein the contact plane is oriented perpendicular to the radial plane.

16. said zero dose stop (340) is provided at the proximal end of said dispensing member (330); and / or The drug delivery device (10, 200, 220, 222, 225) of claim 13, wherein the zero stop feature (196) is provided at a proximal end of a housing cavity (189) of the housing (3, 43, 210, 221, 223, 226).

17. 14. The drug delivery device (10, 200, 220, 222, 225) of claim 13, wherein the zero stop feature (196) and the maximum stop feature (190) are provided on the same structural element of the housing (3, 43, 210, 221, 223, 226).

18. 18. The drug delivery device (10, 200, 220, 222, 225) of claim 17, wherein the structural element comprises a dose thread (185) that threadably engages the dispensing member (330).

19. 3. A drug delivery device (10, 200, 220, 222, 225) according to claim 1 or 2, wherein the dose selector member (35, 310) is axially fixed relative to the dosing member (330) during dose setting.

20. the dose selector member (35, 310) is connected to the housing (3, 43, 210, 221, 223, 226) via connections (187, 188, 315, 316) that allow the dose selector member (35, 310) to be mounted to the housing (3, 43, 210, 221, 223, 226) only in a rotational direction that ensures that the dose setting member (31, 290) is set to a dose position upon engagement of the maximum dose stop (337) with the maximum stop feature (190), A drug delivery device (10, 200, 220, 222, 225) as described in claim 1 or 2, wherein the connection (187, 188, 315, 316) comprises a spline connection that allows axial movement of the dose selector member (35, 310) relative to the housing (3, 43, 210, 221, 223, 226) and prevents rotational movement.

21. 21. The drug delivery device (10, 200, 220, 222, 225) of claim 20, wherein the connection allows for only a single rotational direction.

22. A drug delivery device (10, 200, 220, 222, 225) as described in claim 20, wherein the spline connection includes a set of coding splines, the coding splines having respective dimensions of width and / or height that differ from one another.

23. 23. The drug delivery device (10, 200, 220, 222, 225) of claim 22, wherein the spline connection includes a single coding spline (187, 315) that is different from the remaining splines (188, 316) of the connection (187, 188, 315, 316).

24. 3. A drug delivery device (10, 200, 220, 222, 225) as described in claim 1 or 2, wherein the administration member (330) is coupled to the piston rod (42, 240) via an advancement mechanism that converts axial movement of the administration member (330) into axial advancement of the piston rod (42, 240) during dose delivery, such that axial movement of the administration member (330) during dose delivery advances the piston rod (42, 240) axially in the proximal direction.

25. 25. The drug delivery device (10, 200, 220, 222, 225) of claim 24, wherein the advancement mechanism is configured as a gearing mechanism that reduces the axial movement of the administration member (330) to a smaller axial advancement of the piston rod (42, 240).

26. The piston rod (42, 240) is fixed in a rotational direction relative to the housing (3, 43, 210, 221, 223, 226), the advancement mechanism includes a nut (36, 250) coupled between the piston rod (42, 240) and the dispensing member (330); the nut (36, 250) is threadably connected to the piston rod (42, 240); during dose setting, the nut (36, 250) is rotationally fixed relative to the dispensing member (330) and rotatable relative to the housing (3, 43, 210, 221, 223, 226); 25. A drug delivery device (10, 200, 220, 222, 225) according to claim 24, wherein the nut (36, 250) is rotatable relative to the dosing member (330) and rotationally fixed relative to the housing (3, 43, 210, 221, 223, 226) during dose delivery.

27. A drug delivery device (10, 200, 220, 222, 225) comprising: a housing (3, 43, 210, 221, 223, 226) having a longitudinal axis (207); a dose setting member (31, 290) actuatable by a user and rotatable about said longitudinal axis (207) to set the dose delivered by said drug delivery device (10, 200, 220, 222, 225); a piston rod (42, 240) configured to be axially advanced proximally to deliver the set dose; a dosing member (330) for defining the axial advancement of the piston rod (42, 240) during delivery of the set dose; said dispensing member (330) being axially movable along said longitudinal axis (207) during dose setting and pivotally movable about said longitudinal axis (207); the dispensing member (330) is rotationally fixed relative to the dose setting member (31, 290) during dose setting; said dispensing member (330) comprising a zero dose stop (340); the zero dose stop (340) is configured to engage with a zero stop feature (196) to limit movement of the dispensing member (330) relative to the housing (3, 43, 210, 221, 223, 226) when setting a zero dose; the zero stop feature (196) is provided on the housing (3, 43, 210, 221, 223, 226); the drug delivery device (10, 200, 220, 222, 225) comprises a dose setting mechanism (232) for defining a rotational dose position of the dose setting member (31, 290) relative to the housing (3, 43, 210, 221, 223, 226); the dose setting member (31, 290) is connected to the housing (3, 43, 210, 221, 223, 226) via a dose selector member (35, 310); the dose selector member (35, 310) is rotationally fixed and axially movable relative to the housing (3, 43, 210, 221, 223, 226); the dose selector member (35, 310) is configured to move distally from the housing (3, 43, 210, 221, 223, 226); the dose-measuring mechanism (232) acts between the dose selector member (35, 310) and the dose-setting member (31, 290), or A drug delivery device (10, 200, 220, 222, 225), wherein the dose regulation mechanism (232) acts between the dose selector member (35, 310) and the dispensing member (330).

28. 28. A drug delivery device (10, 200, 220, 222, 225) according to claim 27, wherein the dosing member (330) is pivotally movable relative to the dose setting member (31, 290) during dose delivery.

29. said zero dose stop (340) engages said zero stop feature (196) in a contact plane that is angled relative to a radial plane perpendicular to said longitudinal axis (207); 29. The drug delivery device (10, 200, 220, 222, 225) of claim 27 or 28, wherein the contact plane is oriented perpendicular to the radial plane.

30. A drug delivery device (10, 200, 220, 222, 225) as described in claim 27 or 28, wherein the zero dose stop portion (340) of the dispensing member (330) includes a stop surface configured to abut a corresponding stop surface of the housing (3, 43, 210, 221, 223, 226).

31. said zero dose stop (340) is provided at the proximal end of said dispensing member (330); and / or 29. A drug delivery device (10, 200, 220, 222, 225) according to claim 27 or 28, wherein the zero stop feature (196) is provided at a proximal end of a housing cavity (189) of the housing (3, 43, 210, 221, 223, 226).

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