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 Art

[0002] Drug delivery devices such as injection devices are used in medical applications to deliver drugs, which are usually liquids, to drug delivery sites such as injection sites. For drug delivery that needs to be carried out multiple times within a relatively short time scale in units such as a week, a day or even an hour, for example, in an emergency situation, drug delivery devices that can be used by people who have not received medical training, such as patients, to self-administer their respective drugs have been developed. The uses of such devices can include, for example, diabetes, hormone therapy, anticoagulant therapy, administration of adrenaline, and the like. Among known types of drug delivery devices that can be manually, semi-automatically or automatically actuated to eject drugs 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 it cannot eject further doses of the drug. For single-use devices, the device is discarded after a single dose is ejected, while multi-use devices allow several doses to be repeatedly ejected 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 container becoming empty as described above can occur after one dose ejection or after several dose ejections. Resetting may require, for example, moving the piston rod back into the housing of the device so that a new container can be attached to the device.

[0005] To control the amount of drug delivered, drug delivery devices typically include a dose-setting mechanism that is activatable by the device user and defines configurable doses. To ensure safe and failure-free use of the device, for example, to prevent accidental overdoses, it is necessary to ensure that users are only able to set doses within a limited range of configurable doses. Furthermore, it is necessary to ensure that each set dose precisely corresponds to a predetermined amount of drug dispensed from the device. [Overview of the Initiative]

[0006] Therefore, there is a need to provide a dose delivery device that enables precise and safe dose setting.

[0007] This disclosure provides a drug delivery device as described in an independent claim. Embodiments are given in the dependent claims, this specification and the drawings.

[0008] In a first embodiment, the disclosure relates to a drug delivery device comprising: a housing having a longitudinal axis; a dose setting member that is operable by a user and rotatable about the longitudinal axis for setting a dose to be delivered by the drug delivery device; a piston rod configured to advance proximally in the axial direction for delivering the set dose; and a dosing member for defining the axial advance of the piston rod when delivering the set dose. The dosing member is axially movable along the longitudinal axis during dose setting and is rotatable about the longitudinal axis, and the dosing member is configured to define the axial advance of the piston rod during dose setting. In contrast Rotation direction It is fixed in place. Furthermore, the administration member is equipped with a maximum dose stop section, which is configured to engage with a maximum stop feature section to restrict the movement of the administration member relative to the housing when the maximum dose is set. The maximum stop feature section is provided in the housing.

[0009] The engagement between the maximum dose stop section and the maximum stop feature section allows for the reliable limitation of the dose range definable by the dispensing member to the maximum dose. By providing the maximum stop feature section in the housing, a precise and robust reference position is established that prevents exceeding the upper limit, even when the user applies considerable force during dose setting.

[0010] The axial advance of the piston rod during dose delivery may be directly proportional to the amount of drug being delivered. Therefore, the set dose is also defined by defining the axial advance of the piston rod. For example, in the drug delivery device according to this disclosure, the piston rod may act on a piston that seals a cartridge containing the drug to be delivered, in which case the axial advance of the piston rod during dose delivery may be proportional to the amount of drug being delivered.

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

[0012] The maximum dose stop unit and the maximum stop feature unit may engage directly with each other when setting the maximum dose. Alternatively, the maximum dose stop unit and the maximum stop feature unit may also engage with each other only when the dose setting member has rotated a predetermined amount beyond the rotational position corresponding to the maximum dose.

[0013] According to one embodiment, the dispensing member is rotatable relative to the dose setting member during dose delivery. This can prevent, for example, operation of the dose setting member during dose delivery from being redirected to the dispensing member and thus interfering with the drug delivery process. For example, the dose setting member can be prevented from rotating relative to the housing during dose delivery, while the dispensing member is configured to rotate relative to the housing so that the set dose is delivered.

[0014] The drug delivery device may include, for example, a clutch mechanism provided between a dose setting member and a dispensing member, which irremoves the dose setting member and the dispensing member during dose setting and disengages them during dose delivery. The transition of the clutch mechanism from its coupled or closed state to its disengaged or open state may be influenced, for example, by pressing an operating member of the drug delivery device to initiate the dose delivery process.

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

[0016] By not limiting the movement of the dispensing element to at least one complete rotation, a wide range of configurable doses and / or a closely spaced set of doses can be provided. This makes it possible to adapt the dose-regulating mechanism of the drug delivery device to a wide range of applications.

[0017] According to one embodiment, the administration member is screw-connected to the housing, for example, via an external thread provided on the administration member and a corresponding internal thread provided on the housing. In this case, the screw connection can define the ratio between the axial movement and rotational movement of the administration member during dose setting and / or dose delivery. By providing both a screw connection and a maximum stop feature on the housing of the drug delivery device, the movement of the administration member can be precisely and reliably restricted.

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

[0019] According to one embodiment, the maximum dose stop unit includes a stop surface configured to abut axially against the maximum stop feature portion of the housing when setting the maximum dose. Therefore, the maximum dose stop unit abuts against the maximum stop feature portion by moving parallel to the longitudinal axis of the device. This makes it possible to precisely restrict the axial movement of the administration member.

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

[0021] According to one embodiment, the stopping surface is an annular surface that surrounds the longitudinal axis. This ensures that the maximum dose stopping portion engages with the maximum stopping feature portion regardless of the rotational position of the administration member with respect to the longitudinal axis.

[0022] Generally, the maximum stopping feature can be configured to cover only a limited angular position about the longitudinal axis in a cross-section perpendicular to the longitudinal axis. If the drug delivery device has several maximum stopping features, the set of maximum stopping features can similarly be configured to cover only a limited angular position. In this case, configuring the stopping surface to be oriented perpendicular to the longitudinal axis and / or configuring the stopping surface as an annular surface can prevent the axial position of the delivery member when engaging with the maximum stopping feature from depending on its rotational position.

[0023] According to one embodiment, the maximum dose stop portion protrudes from the outer surface of the administration member. Therefore, the position of the administration member when engaging with the maximum dose stop feature portion can be flexibly designed by selecting the position of the maximum dose stop portion on the outer surface of the administration member.

[0024] According to one embodiment, the maximum stop feature projects from the inner surface of the housing. This makes it possible to stop the movement of the dosing member before it reaches the end of the housing. Further, the position of the dosing member at the time of engagement with the maximum stop feature can be flexibly designed by selecting 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. This makes it possible to provide additional space at the end of the dosing member for engagement with other components of the drug delivery device, such as components that provide a clutch mechanism of the device and / or components that transmit an axial force 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, and the maximum dose stop engages with the limiting surface during the setting of the maximum dose. The limiting surface may be oriented perpendicular to the longitudinal axis, for example. The limiting surface may be configured as a flat surface, for example.

[0027] According to one embodiment, the maximum stop feature of the housing is provided on a flexible element configured to snap fit over the maximum dose stop of the dosing member during the assembly of the drug delivery device. This enables easy assembly of the device.

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

[0029] According to one embodiment, the flexible element bears against a backing element, such as an outer housing that surrounds an inner housing having the flexible element, to prevent the maximum stop feature from disengaging from the maximum dose stop after the assembly of the drug delivery device. This ensures that the movement of the dosing member is reliably stopped when engaging with the maximum stop feature.

[0030] According to one embodiment, the dosing member is configured as a dosing indicating member that provides the user with a visual indicator of the set dose, for example via a corresponding optical marker on the outer surface of the dosing member. By providing a maximum dose stop on the dosing member, the movement of the dosing indicating member is restricted during dose setting, so that the set dose is precisely indicated. For example, the setting of the 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 dosing member during dose setting. Such axial movement of the dose setting member provides tactile feedback to the user of the device and can thus assist users with visual impairments. Furthermore, the dose setting member can be configured as an actuating member that is pushed back by the user of the device to allow the drug to be delivered.

[0032] According to one embodiment, the dosing member comprises a zero dose stop, which is configured to engage with a zero stop feature to limit the movement of the dosing member relative to the housing when the dosing member reaches the zero dose position, the zero stop feature being provided on the housing. By defining the zero dose position via the engagement between the dosing 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 an individual dose setting and thus prevents inadvertent under- or over-injection.

[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 precise zero dose stop mechanism configured to receive a relatively large force. 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-to-face.

[0034] According to one embodiment, the zero-dose stop of the administration member includes a stop surface configured to abut against a corresponding stop surface of the housing. The stop surfaces may be oriented parallel to each other. Additionally or alternatively, these 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 administration member reaches the zero-dose position.

[0035] According to one embodiment, the zero-dose stop portion is provided at the proximal end of the administration member. Such a zero-dose stop portion can be easily engaged by a zero-stop feature portion when the administration member moves proximal toward the zero-dose position.

[0036] According to one embodiment, the zero-stop feature is provided at the proximal end of the housing cavity of the housing. Such a zero-stop feature can be easily engaged by the zero-dose stop when the dosing member moves proximal toward 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, in the inner housing. This makes it possible to precisely define the position of the dosing member at which it engages with the corresponding stop feature. As a result, the axial distance the dosing member travels between the stop features, and therefore the amount of drug corresponding to each individual dose setting, are also precisely defined.

[0038] According to one embodiment, the structural element is provided with a dose thread that engages with the dosing member in a screw-like manner. Thus, the structural element can also define the axial and rotational positions of the dosing member corresponding to individual dose settings. This further enhances the reliability and reproducibility of dose setting and dose delivery.

[0039] According to one embodiment, a structural element is provided with a drive thread that engages screw-type with a driver of a drug delivery device, and the driver is coupled to the piston rod during dose delivery to advance the piston rod axially when the driver moves axially. By providing both the stopping feature and the drive thread on the same structural element, the axial distance the piston rod travels during dose delivery is precisely coupled to the axial position of the dispensing member, thus providing high dose accuracy.

[0040] According to one embodiment, the drug delivery device includes a dose setting mechanism for defining the rotational dose position of a dose setting member relative to the housing, and the dose setting member is connected to the housing via a dose selector member. Thus, the dose selector member rotates relative to the housing. direction The dose selection mechanism is fixed to the housing and movable axially, and operates between the dose selector member and the dose setting member. Such a dose selector member allows the rotational position of the administration member corresponding to each configurable dose to be directly defined within the administration member itself, thus enabling the drug delivery device to be constructed simply and 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.

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

[0042] According to one embodiment, the dose selector member is fixed axially to the administration member. This makes it possible to efficiently transmit axial force from the dose selector member to the administration 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 in the housing only in a rotational direction that ensures the dose setting member is set to the dose position when it engages with the maximum stop feature of the maximum dose stop unit, for example, the connection allows only a single rotational direction. This facilitates the assembly of the drug delivery device.

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

[0045] According to one embodiment, the spline connection includes a single coding spline that is distinct from the rest of the splines in the connection. Such a connection has a simple structure, but nevertheless enables reliable coding functionality.

[0046] According to one embodiment, the dosing member is coupled to a piston rod via a forward mechanism that converts the axial movement of the dosing member into axial forward movement of the piston rod during dose delivery, so that the axial movement of the dosing member during dose delivery causes the piston rod to advance proximal in the axial direction. Such a forward mechanism may include, for example, one or more additional members of the drug delivery device.

[0047] According to the drug delivery device of this disclosure, the forward mechanism may include, for example, a driver and a nut, wherein the driver is coupled between the delivery member and the nut, and the nut is coupled between the driver and the piston rod.

[0048] According to one embodiment, the forward movement mechanism is configured as a gearing mechanism that reduces the axial movement of the dispensing member to a smaller axial forward movement of the piston rod. As a result, the axial force applied to the dispensing member is converted by the piston rod into a larger axial force, for example, on a plunger that seals a cartridge containing the drug to be delivered. This makes it possible to easily deliver the drug regardless of its viscosity.

[0049] According to one embodiment, the piston rod rotates relative to the housing direction The forward mechanism is fixed and includes a nut connecting the piston rod and the dispensing member. The nut is screw-connected to the piston rod. During dose setting, the nut rotates relative to the dispensing member. direction It is fixed to the housing and rotatable relative to the housing. Furthermore, the nut is rotatable relative to the dispensing member during dose delivery and rotatable relative to the housing. direction It will be fixed in place.

[0050] Such a structure of the forward mechanism allows the nut and the dosing member to rotate simultaneously during dose setting, thus enabling 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 screw-engaged with each other but not allowed to rotate relative to each other, move in concert 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 by each dose delivery.

[0051] According to one embodiment, the forward mechanism comprises a driver coupled between a nut and a dosing member, and the driver, during both dose setting and dose delivery, to the dosing member. In contrast Rotation directionThe driver is fixed to the housing and movable axially relative to the dispensing member. The driver is further screw-coupled to the housing and configured to engage with the nut during dose delivery, causing the nut and piston rod to advance axially as it is rotated by the dispensing member. Such a driver allows for the implementation of a gearing mechanism having a gear ratio determined by the pitch of the screw connection between the driver and the housing, and the pitch of the further screw connection between the dispensing member and the housing.

[0052] The drug delivery devices according to this disclosure do not necessarily have a maximum dose stop section with a maximum stop feature provided in the housing and a maximum dose stop section provided in the delivery member in order to reliably define the axial movement of the delivery member during dose delivery and thus enable precise and safe dose setting and dose delivery. According to this disclosure, reliable definition of the axial movement of the delivery member can also be achieved by providing a zero dose stop section that acts directly between the housing and the delivery member.

[0053] Accordingly, in a second embodiment, the present disclosure relates to a drug delivery device comprising: a housing having a longitudinal axis; a dose setting member that is operable by a user and rotatable about the longitudinal axis for setting a dose to be delivered by the drug delivery device; a piston rod configured to advance proximal in the axial direction for delivering the set dose; and a dosing member for defining the axial advance of the piston rod when delivering the set dose. The dosing member is axially movable along the longitudinal axis during dose setting and is rotatable about the longitudinal axis. Furthermore, the dosing member is configured to control the dose setting member during dose setting. In contrast Rotation direction The administration member is fixed in place. The administration member includes a zero-dose stop section configured to engage with a zero-stop section to restrict the movement of the administration member relative to the housing when setting a zero dose, and the zero-stop section is provided in the housing.

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

[0055] In a third embodiment, the disclosure relates to a drug delivery device comprising a housing having a longitudinal axis, a dose setting member that is operable by a user and rotatable about the longitudinal axis for setting a dose to be delivered by the drug delivery device, a piston rod configured to advance proximally in the axial direction for delivering the set dose, and a dosing member for defining the axial advance of the piston rod when delivering the set dose. The dosing member is axially movable along the longitudinal axis during dose setting, rotatable about the longitudinal axis, and controls the dose setting member during dose setting. In contrast Rotation direction The dose setting member is fixed to the housing via a dose selector member, thereby allowing the dose selector member to rotate relative to the housing. direction It is fixed and movable in the axial direction. The drug delivery device further comprises a dose setting mechanism for defining the rotational dose position of the dose setting member relative to the housing, thereby the dose setting mechanism operates between the dose selector member and the dose setting member.

[0056] A dose setting mechanism having such a dose selector member allows the rotational position of the dispensing member corresponding to each configurable dose to be directly determined within the dispensing member itself, and thus the drug delivery device can be constructed simply and robustly. Due to the axial mobility of the dose selector member, individual doses can be set regardless of the axial position of the dose setting member during dose setting.

[0057] The dose setting member may be axially movable with respect to the dose selector member, and / or the dose selector member may be fixed axially with respect to the administration member.

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

[0059] According to all drug delivery devices of this disclosure, the pharmaceuticals stored in the device's cartridge may be selected from a group of members consisting of diabetes medications such as insulin, growth hormones, reproductive hormones, osteoporosis medications, anticoagulants such as heparin, and medications for migraines, HIV-associated nephropathy, non-alcoholic fatty liver disease, or obesity.

[0060] Exemplary embodiments and functions of this disclosure are described herein with reference to the accompanying drawings, which schematically illustrate the following. [Brief explanation of the drawing]

[0061] [Figure 1] This is a perspective view of the drug delivery device according to this disclosure, with a cap attached. [Figure 2] This is a perspective view of a drug delivery device with the cap removed and the dispensing unit attached. [Figure 3] This is a perspective view of a drug delivery device, cap, and dispensing unit. [Figure 4] This is a side view of a distribution unit comprising a cartridge holder, a cartridge, and a needle that can be attached to the distribution unit. [Figure 5] This is a longitudinal cross-sectional view of a drug delivery device, dispensing unit, and cap through a first cross-section, showing the drug delivery device in a dose-setting state. [Figure 6] This is a longitudinal cross-sectional view of a drug delivery device, a first dispensing unit, and a cap, taken through a second cross-section perpendicular to a first cross-section, with the drug delivery device in a dose-setting state. [Figure 7] This is a decomposed diagram of the drug delivery device's administration mechanism. [Figure 8] This is a longitudinal cross-sectional view of the administration mechanism of a drug delivery device through a first cross-section, before dose setting. [Figure 9] This is a longitudinal cross-sectional view of the administration mechanism through the first cross-section, showing the administration mechanism in the dose-setting state, after the dose has been set. [Figure 10] This is a longitudinal cross-sectional view of the administration mechanism through a first cross-section, after the dose has been set and the administration mechanism is in a dose-delivery state. [Figure 11] This is a longitudinal cross-sectional view of the administration mechanism through the first cross-section, after the dose has been delivered and the administration mechanism is in the dose-setting state. [Figure 12] This is a diagram of the clutch mechanism of the administration mechanism in the dose setting state. [Figure 13] This is a diagram of the clutch mechanism in a dose delivery state. [Figure 14] This is a radial cross-sectional view of a drug delivery device through its dose-regulating mechanism. [Figure 15] This is a perspective view of the proximal side of the dose setting component of a drug delivery device. [Figure 16] This is a distal perspective view of the clutch component of a drug delivery device. [Figure 17] This is a perspective view of the proximal side of the clutch component of a drug delivery device. [Figure 18] This is a longitudinal cross-sectional view through the administration member and dose selector member of a drug delivery device having a first friction reduction mechanism. [Figure 19] This is a perspective view of the connection between the nut and the driver of a drug delivery device having a second friction reduction mechanism. [Figure 20] This is a perspective view of the administration component of a drug delivery device. [Figure 21] This is a longitudinal cross-sectional view through the inner housing of a drug delivery device. [Figure 22] This is a perspective view of the inner housing with the administration component in the zero-dose position. [Figure 23] This is a perspective view of the inner housing with the dispensing element in the maximum dose position. [Figure 24] This is a longitudinal cross-sectional view through the outer housing of a drug delivery device. [Figure 25] This is a longitudinal cross-sectional view through the inner housing, which is mounted within the outer housing of a drug delivery device. [Figure 26] This is a radial cross-sectional view of a drug delivery device through its outer and inner housings. [Figure 27] This is a disassembled partial diagram of the reset mechanism of a drug delivery device. [Figure 28] This is a longitudinal cross-sectional view through the reset mechanism of a drug delivery device where the reset element is located proximal to the device. [Figure 29] This is a distal perspective view of the reset element of the reset mechanism. [Figure 30] This is a proximal perspective view of the reset element. [Figure 31] This is a proximal perspective view of the coupling portion of the reset mechanism. [Figure 32] This is a perspective view of the joint and inner housing. [Figure 33] This is a longitudinal cross-sectional view through a reset mechanism, where the distribution unit is attached to the drug delivery device and the reset element is located distally. [Figure 34] This is a longitudinal cross-sectional view through the proximal end of a cartridge holder that can be attached to a drug delivery device. [Figure 35] This is a distal perspective view of a radial cross-section through the proximal portion of the cartridge holder. [Figure 36]This figure shows longitudinal cross-sections through a first distribution unit that can be attached to a first drug delivery device, longitudinal cross-sections through a second distribution unit that can be attached to a second drug delivery device, and longitudinal cross-sections through a third distribution unit that can be attached to a third drug delivery device. [Figure 37] This figure shows a longitudinal cross-section of a first drug delivery device through its first connecting means and a perspective view of the first connecting means, a longitudinal cross-section of a second drug delivery device through its second connecting means and a perspective view of the second connecting means, and a longitudinal cross-section of a third drug delivery device through its third connecting means and a perspective view of the third connecting means. [Figure 38] This disclosure provides a further perspective on drug delivery devices. [Figure 39] This is a diagram of a further drug delivery device with the cap removed. [Figure 40] This is an exploded view of a further drug delivery device. [Figure 41] This is a diagram of the clutch mechanism of a further drug delivery device. [Figure 42] This is a diagram of a dose setting component for a further drug delivery device. [Figure 43] This is a diagram of a dose selector component for a further drug delivery device. [Figure 44] This is a diagram of an alternative embodiment of the reset element of a drug delivery device. [Figure 45] This is a longitudinal cross-sectional view through an alternative embodiment of the reset element. [Figure 46] This is a diagram of an alternative embodiment of the coupling portion of a drug delivery device. [Figure 47] This figure shows an alternative embodiment of the reset element and an alternative embodiment of the coupling portion mounted on an alternative embodiment of the inner housing of the drug delivery device. [Figure 48] This 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]This 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] This diagram shows an alternative embodiment of the inner housing, dose selector member, and administration member, where the administration member is in the zero dose position. [Figure 51] This diagram shows an alternative embodiment of the inner housing, dose selector member, and dose member, with the dose member in the maximum dose position. [Figure 52] This is a diagram of an alternative embodiment of the clutch member. [Figure 53] This is a diagram of a drug delivery device having a further alternative embodiment of the inner housing, in which the counterweight is located on the outer surface of the inner housing. [Figure 54] This is a radial cross-sectional view perpendicular to the longitudinal axis passing through a drug delivery device having a counterweight. [Figure 55] This is a diagram of an alternative embodiment of the inner housing. [Figure 56] This is a diagram of a counterweight. [Figure 57] This 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] This is a longitudinal cross-sectional view through the first, second, and third distribution units, showing additional dimensions. [Figure 59] The images show additional dimensions of the first drug delivery device, the second drug delivery device, and the third drug delivery device, including longitudinal sections through the first, second, and third connecting means, as well as perspective views of the first, second, and third connecting means. [Modes for carrying out the invention]

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

[0063] The present disclosure of the reset mechanism is applicable with multiple drug delivery devices, such as infusion devices. One possible infusion device is a pen-type design illustrated in Figure 1.

[0064] Figure 1 shows a drug delivery device 200 comprising connecting means for mounting a distribution 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 the proximal end 205 of the housing 210. At the distal end 206 of the housing 210, the drug delivery device 200 comprises a dose setting member 290, the distal end 206 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 grasped and rotated by the user of the device 200 to set the dose to be delivered by the device 200. Thus, the dose setting member 290 can also be thought of as a knob or the like. In the embodiment shown in Figure 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 that surrounds the longitudinal axis 207.

[0066] The dose setting member 290 is rotatably locked to the housing 210 and connected to the housing 210 via a dose selector member 310 that is axially movable, during both dose setting and dose delivery. When the set dose is increased by swiveling the dose setting member 290 relative to the housing 210 and the dose selector member 310, the dose selector member 310 moves distally from the housing 210, and thus the dose setting member 290 also moves distally.

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

[0068] The dose indicator member 330 is also configured as a generally tubular member and carries a dose scale on its cylindrical outer surface, which includes several optical markers 331 corresponding to each set dose. When setting a dose, the dose indicator member 330 rotates within the inner housing 180, thereby changing the position of the scale, and therefore the optical markers 331, visible through the windows 211a and 180a.

[0069] Figure 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. Figure 3 shows the cap 209 and dispensing unit 410 removed from the drug delivery device 200. By attaching the cap 209 and dispensing unit 410 to the housing 210 of the device 200, the dispensing unit 410 is fully received within the cap 209.

[0070] The dispensing unit 410 comprises a cartridge holder 412 made from a plastic material in the present embodiment. 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, the connection including a first connecting means 510 located at the proximal end of the housing 210 and a corresponding first connecting means 414 located at the distal end of the dispensing unit 410. The first connecting 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 connecting 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 distribution unit 410 includes 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 screw 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] Figure 4 shows the cartridge holder 412 of the distribution unit 410, a cartridge 8 that can be inserted into the cartridge holder 412, and a needle 4 that can be attached to the needle connector 402.

[0073] In this embodiment, the cartridge 8 is made of glass and has a generally cylindrical body that encloses a drug compartment 81 containing a liquid drug to be delivered by the drug delivery device 200. At its distal end, the drug compartment 81 is sealed by an elastic plunger 9 that is movable along the longitudinal axis within the body of the cartridge 8. At its proximal end, the cartridge 8 has an annular rim 82, which is separated from the body by an annular detent 85 located distal to the annular rim 82. On the proximal front surface of the cartridge 8, which is oriented perpendicular to the longitudinal axis 207, the cartridge 8 has sealing means or partition wall 8a that 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 held in the inserted position in an irremovable manner 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 notch in the cartridge holder 412. When the cartridge 8 is inserted into the cartridge holder 412, the connector 404 snaps into place on the annular rim 82 of the cartridge 8. At this time, the radially inwardly projecting fingers of the connector 404 are located within the annular detent 85 of the cartridge 8 and contact the distal surface 83 of the annular rim 82, thereby preventing distal movement of the cartridge 8.

[0075] This non-releasable connection between cartridge 8 and cartridge holder 412 prevents cartridge 8 from detaching from cartridge holder 412 during the intended use of the distribution unit 410. For example, this connection prevents cartridge 8 from detaching unless connector 404 is intentionally and / or forcefully pulled from its engagement with the annular rim 82. Thus, the non-releasable connection is configured such that such disengagement is only possible with a tool or by using an excessive force greater than the force acting on the non-releasable connection during the normal and / or intended use of the distribution unit 410, for example, during mounting of the distribution unit 410 into housing 210, during mounting of needle 4 into cartridge holder 412, or during handling of the distribution unit 410 with cartridge 8 inserted into cartridge holder 412. This handling may also occur during transport and / or unintentional drops of the distribution unit and may include impact forces that do not exert a force that would destroy the distribution unit 410 and / or cartridge holder 412 and / or cartridge 8. The non-releasable connection between the cartridge 8 and the cartridge holder 412 allows the distribution unit 410 with the inserted cartridge 8 to be offered and sold as a single pre-installed unit.

[0076] The needle 4 is configured as a pen needle. The needle comprises a hub 5 that carries a double-ended cannula 6. The cannula 6 is received longitudinally within the hub 5. The hub 5 has 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 sharp ends at both its proximal and distal ends. Its distal end punctures 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 the user of the device 200, thereby enabling the injection of the drug into the delivery site.

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

[0078] The administration mechanism 230 comprises a piston rod assembly having a piston rod 240 that is elongated along the longitudinal axis 207 and a plunger disc 242 (see Figures 5 and 6) mounted on the proximal end of the piston rod 240. The piston rod assembly is configured to directly contact the plunger 9 by the plunger disc 242 and to advance the plunger 9 within the cartridge 8 in response to the proximal movement of the piston rod assembly. The piston rod 240 has a non-circular cross-section and an external thread 241 that essentially covers 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 which terminates the external thread 241 and is exemplary configured as a thickened portion of the piston rod 240 having a radially extending range larger than the smallest diameter of the thread 241.

[0079] The piston rod 240 is located within the housing 210, i.e., within the outer housing 211 and the inner housing 180. During use, the piston rod 240 can protrude from the proximal end of the housing 210, and as a result, the plunger disc 242 can move 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 installing a new distribution unit 410 into the device 200. During use of the device 200, the piston rod 240 is moved proximal and also protrudes from the outer housing 211. The plunger disc 242 is permanently located outside the inner housing 180 and can be fully retracted into the outer housing 211, for example, after the completion of a reset operation and / or before and / or immediately after installing a new distribution unit 410 into the device 200.

[0080] The piston rod 240 rotates relative to the housing 210 during both dose setting and dose delivery. direction It locks in place. In this embodiment, the piston rod 240 is connected to the housing 210 via the reset element 110 of the reset mechanism 100 of the drug delivery device 200. See Figures 5 and 6. The reset element 110 rotates relative to the housing 210 during both dose delivery and dose setting. direction The reset element is fixed to the reset element. The reset element has a longitudinal opening 114 that receives the piston rod 240, so that the plunger disc 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 engages screw-like with the threads 241 of the piston rod 240. In this embodiment, the nut 250 includes a screw section having internal threads 256 that engage with the external threads 241 of the piston rod 240. The screw section is located within the proximal portion 251 of the nut 250, at the proximal end of the nut 250. According to other embodiments, the screw section may also cover other portions of the nut 250 or be located within other portions of the nut 250. The nut 250 further permanently surrounds the stop feature portion 243 of the piston rod 240, regardless of the set dose and / or the dose delivered.

[0082] The nut 250 has a distal portion 252 that is surrounded by the proximal portion 274 of the clutch member 270 of the administration mechanism 230. In contrast Rotation direction It is fixed to the clutch member 270 and is movable in the axial direction.

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

[0084] According to another embodiment, rotation between the nut 250 and the clutch member 270 direction The connection, which is fixed and axially movable, may also be achieved by different means, for example, by a spline connection between a longitudinal ridge on the outer surface of the nut 250 and a corresponding longitudinal groove 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 to the dose setting member 290 at its distal end by a connection 277 that prevents both relative axial movement 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] In its proximal portion 251, the nut 250 is surrounded by a driver 350. The driver 350 is constructed as a hollow, generally cylindrical member. Furthermore, the driver 350 is movable both axially and rotationally relative to the housing 210 during both dose setting and dose delivery. Thus, the driver 350 engages with the housing 210 in a screw-like manner.

[0087] The inner housing 180 includes an inner sleeve 183 at its proximal end to receive the proximal portion 351 of the driver 350. The driver 350 has threads 353 that engage with the drive threads 186 of the inner sleeve 183. In an exemplary embodiment, the threads 353 of the driver 350 are configured as external threads, and the drive threads 186 are configured as internal threads. The threads 353 are located on the proximal portion 351 of the driver 350. According to other embodiments, the screw connection between the driver 350 and the housing 210 may also be achieved in other ways, for example, by external threads on the housing 210 and internal threads on the driver 350.

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

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

[0090] The dispensing member 330 is axially movable and rotatable relative to the housing 210 during both dose setting and dose delivery. The dispensing member is further screw-engaged with the housing 210, thereby forcing it to move along a helical path relative to the housing 210.

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

[0092] The administration member 330 is configured as a dose indicator member and is provided with 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 screw threads 335 on the outer surface of the administration member 330.

[0093] The driver 350 is axially movable and rotatable relative to the dispensing member 330 during both dose setting and dose delivery. direction It is fixed in place. According to an exemplary embodiment, this is achieved by a spline connection between the driver 350 and the dosing member 330.

[0094] The driver 350 includes a radially extending longitudinal spline 360 ​​that engages with a corresponding longitudinal groove 341 provided on the inner surface of the dosing member 330 (see Figure 6). The spline 360 ​​is located within the distal portion 359 of the driver 350, and the groove 341 is located within the proximal portion 332 of the dosing member 330. According to other embodiments, the spline connection between the driver 350 and the dosing member 330 may also be achieved in a different manner. For example, the driver 350 may include a groove that engages with the corresponding spline of the dosing 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 fixed in the axial direction and rotatable relative to the administration member 330. Therefore, the dose selector member 310 is forced to follow the movement of the administration member 330 in the axial direction, while the administration member 330 itself rotates relative to the housing 210. direction It can rotate freely relative to the dose selector member 310 which is fixed to it.

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

[0098] Figure 8 shows a longitudinal cross-section of the administration mechanism 230 of the drug delivery device 200 through a first cross-section, before setting the dose to be delivered by the drug delivery device 200. To set the dose, the dose setting member 290 is grasped by the user and rotated relative to the housing 210. This causes the clutch member 270 to rotate together with the dose setting member 290. Rotation between the clutch member 270 and the nut 250 direction Due to the fixed connection, the nut 250 also rotates together with the dose setting member 290. The piston rod 240 rotates relative to the housing 210. direction The piston rod 240 is fixed to the nut 250, and since the piston rod 240 is screw-engaged with the nut 250, the rotation of the nut 250 causes the nut 250 to advance axially along the piston rod 240 distally. When the set dose is increased, the nut 250 advances distally, and when the set dose is decreased, the nut 250 advances proximal.

[0099] During dose setting, the dose setting member 290 rotates relative to the administration member 330. direction It is fixed in place. This is achieved by a clutch mechanism 234 which includes a first part 235 that acts between the dose setting member 290 and the administration member 330.

[0100] The first portion 235 of the clutch mechanism 234 includes a clutch element 336 (see Figure 7) located on the dosing member 330 that engages with a corresponding clutch element 273 located on the clutch member 270 during dose setting. The engagement between these clutch elements 336, 273 prevents relative rotational movement between the dose setting member 290 and the dosing member 330, while allowing axial movement for disengaging the first portion 235 of the clutch mechanism 234.

[0101] Since the first portion 235 of the clutch mechanism 234 is closed during dose setting, the dispensing member 330 rotates together with the dose setting member 270. At this time, the screw engagement between the dispensing member 330 and the housing 210 causes the dispensing member 330 to advance axially within the housing 210 during dose setting. When the set dose is increased, the dispensing member 330 advances distally, and when the set dose is decreased, the dispensing member 330 advances proximal.

[0102] Since the dose selector member 310 is fixed axially to the administration member 330, distal movement of the administration member 330 causes the dose selector member 310 to exit the housing 310 distally and advance axially, thereby causing the dose setting member 290 to move distally as well. Simultaneously, proximal movement of the administration member 330 causes the dose selector member 310 to advance axially into the housing 210, thereby causing the dose setting member 290 to move proximal.

[0103] The dispensing member 330 rotates relative to the driver 350. directionBecause it is fixed in place, the rotation of the dispensing member 330 also rotates the driver 350 together with the dose setting member 290. Then, the screw connection between the driver 350 and the housing 210 causes the driver 350 to move distally when the set dose increases and proximal when the set dose decreases.

[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 so that the nut 250 and the driver 350 advance essentially in the same axial direction as a result of the rotational movement of the dose setting member 290. The first and second pitches are smaller than the third pitch of the threaded connection between the dosing member 330 and the housing 210. This allows the dosing member 330 to advance by a greater axial distance than the nut 250 and the driver 350 as a result of the rotation of the dose setting member 290.

[0105] Device 200 locks the nut 250 and clutch member 270 so that they are rotatable only, while allowing them to move freely relative to each other in the axial direction. This allows the clutch member 270 and dose setting member 290 to travel a greater distance in the axial direction than the nut 250 during dose setting. Similarly, the driver 350 and dispensing member 330 are locked so that they are rotatable only, while allowing them to move freely relative to each other in the axial direction. This allows the dispensing member 330 to travel a greater distance in the axial direction than the driver 350 during dose setting.

[0106] Figure 9 shows the dose setting mechanism 232 after the dose has been set. During dose setting, the administration member 330 advances a first distance x distally, the driver 350 advances a second distance y, and the nut 250 advances 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 less than or equal to the minimum second pitch. This ensures that the second distance y by which the driver 350 travels distally is always slightly greater than the third distance z by which the nut 250 travels.

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

[0109] To dispense a set dose, the user of device 200 pushes the actuarial member, formed by the dose setting member 290, from the distal to the proximal portion. This causes the administration mechanism 230 to transition from the dose setting state to the dose delivery state. The administration 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 administration mechanism 230 are in the dose setting state, and to allow delivery of the set dose when the dose delivery device 200 and the administration mechanism 230 are in the dose delivery state.

[0110] Figure 10 shows the administration mechanism 230 after the dose has been set and the administration mechanism 230 has transitioned from the dose setting state to the dose delivery state. By moving the dose setting member 290 proximal, the clutch member 270 also moves proximal. Thus, the first portion 235 of the clutch mechanism 234 opens, and the clutch element 273 of the clutch member 270 is disengaged from the clutch element 336 of the administration member 330. Therefore, the administration member 330 and the driver 350 can rotate freely relative to the dose setting member 290, the clutch member 270, and the nut 250.

[0111] Simultaneously, the proximal movement of the dose setting member 290 relative to the dose selector member 310 closes the second portion 236 of the clutch mechanism 234, and the nut 250 is rotatably locked relative to the piston rod 240 and the housing 210. The second portion 236 of the clutch mechanism 234 acts between the dose selector member 310 and the dose setting member 290 and will be further described below in reference to Figures 12 and 13.

[0112] Next, the dose setting member 290 is pushed further proximally, causing the dose selector member 310 to move linearly and return to the housing 210. Thus, the dose selector member 310 pushes the administration member 330, which in turn causes the administration member 330 to rotate due to its screw-type engagement with the housing 210. The rotation of the administration member 330 is transmitted to the driver 350, and therefore the driver also moves proximally due to its screw-type engagement with the housing 210.

[0113] Thus, the difference between the screw connection pitch between the dosing member 330 and the housing 210 and the screw connection pitch between the driver 350 and the housing 210 is applied by the user, resulting in the mechanical advantage of converting the first axial force acting on the dosing member 330 into a second axial force applied 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 proximal during dose delivery, the driver 350 pushes the nut 250 axially, thereby advancing the nut 250 proximal. The screw connection between the nut 250 and the piston rod 240 prevents the nut 250 from rotating relative to the piston rod 240 during dose delivery due to its connection to the housing 210 via the clutch member 270, dose setting member 290, and dose selector member 310. Thus, during dose delivery, the screw connection between the nut 250 and the piston rod 240 fixes the nut 250 and the piston rod 240 axially relative to each other. Therefore, by moving the nut 250 axially, the piston rod 240 is also prompted to move proximal, thereby advancing the plunger 9 and ejecting the drug from the drug compartment 81.

[0115] A housing 250, a dosing member 330 screw-engaged with the housing 250 and rotatably engaged with a driver 350, a driver 350 also screw-engaged with the housing 250, and a nut 250 pushed proximal by the driver 350 during dose delivery form the forward mechanism of the drug delivery device 200. The forward mechanism is configured to convert the axial movement of the dosing member 330 into axial forward movement of the piston rod 240 during dose delivery. Thus, the forward mechanism includes a gearing mechanism provided by screw connections of different pitches between the housing 250 and the dosing member 330 on one side, and between the housing 250 and the driver 350 on the other side. The gearing mechanism performs the mechanical advantage of converting a first axial force exerted by the user and acting on an actuating member formed by the dose setting member 290 into a second axial force exerted on the plunger 9 by the piston rod 240. This second axial force corresponds to a second axial force exerted on the nut 250 by the driver 350. According to this embodiment, the second axial force is different from the first axial force, that is, it 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 it may be essentially equal to the first axial force.

[0116] Upon receiving a dose, the second portion 236 of the clutch mechanism 234 is closed, thereby rotatably locking 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 therefore, the user is not bothered by the rotation of the dose setting member 290 when pressing the dose setting member 290 to perform dose delivery. The drug delivery device 200 is accessible to the user from the outside of the device 200 and has no components that rotate during dose delivery. This helps to ensure safe delivery of the drug during infusion.

[0117] Figure 11 shows the administration mechanism 230 after the dose has been delivered. The nut 250, driver 350, and administration 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 via the plunger disc 242, and the plunger 9 has also been moved a third distance z in the proximal direction.

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

[0119] In the dose setting state shown in Figure 12, the dose setting member 290 and the clutch member 270 are distal to the dose selector member 310 and the administration member 330. The first portion 235 of the clutch mechanism 234 is closed, rotatably securing the clutch member 270 to the administration member 330.

[0120] A second portion 236 of the clutch mechanism 234 is configured to rotatably secure the dose setting member 290 to the dose selector member 310 during dose delivery. The second portion 236 includes a clutch element 294 (see also Figure 15) provided on the dose setting member 290. As can be seen in Figure 13, by moving the dose setting member 290 to a proximal position, the clutch element 294 engages with a functional feature portion 312 of the dose selector member 311, thereby rotatably locking the dose setting member 290 to the dose selector member 311. The functional feature portion 312 is configured as teeth. The functional feature portion 312 is provided on the inner surface of the distal portion 311 of the dose selector member 310. The functional feature portion constitutes the clutch element of the dose selector member 310. As can be seen in Figure 13, by pushing the dose setting member 290 to a proximal position, the clutch element 273 of the clutch member 270 is disengaged from the clutch element 336 of the administration member 330.

[0121] Generally speaking, the clutch mechanism 234 rotatably locks the nut 250 to the dosing member 330 and / or driver 350 during dose setting, and disengages the nut 250 with respect to rotation from the dosing member 330 and / or driver 350 during dose delivery. Furthermore, generally speaking, the dosing mechanism 230 is configured to prevent relative rotation 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 rotatably 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 rotatably 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 another embodiment of the drug delivery device 200, the dose setting member 290 may also be permanently and rotatably locked to the dosing member 330. For example, such a dose setting member 290 may be configured as part of the dosing member 330, accessible to the user of the device. In this case, such an embodiment of the drug delivery device 200 may include an actuator that can be pressed by the user to perform dose delivery and is separated from the dose setting member 290. In this case, the actuator may be rotationally movable relative to the dose setting member 290, at least during dose delivery. In this case, the nut 250 can be rotationally disengaged from the dosing member 330 by pushing the actuator proximally upon commencement of dose delivery.

[0124] The drug delivery device 200's administration mechanism 230 further comprises a dose setting mechanism 232 acting between two members of the administration mechanism 230 that are movable with respect to rotation relative to each other during dose setting. The dose setting mechanism 232 defines distinct and / or discrete rotational positions of the dose setting member 290 and the administration member 330 relative to the housing 210, corresponding to individual configurable doses of the drug dispensed by the administration mechanism 230. Furthermore, the dose setting mechanism 232 provides auditory and / or tactile feedback to the user of the drug delivery device 200, thereby indicating the rotational positions of the dose setting member 290 and the administration member 330 corresponding to the configurable 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 configurable dose. In this case, the dose setting member 219 assumes a different axial position relative to the housing 210, for example, a discrete axial position, for each individual configurable 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. In this case, the discrete rotation positions of the dose setting member 290 defined by the dose setting mechanism 232 also correspond to distinctly different rotation positions. Generally, by the distinct differences in rotation positions, each individual rotation position corresponds to only a single dose value configurable by the dose setting mechanism 232. According to the drug delivery device 200, the dose-determining 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-determining mechanism 232 is realized by 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 this disclosure, the dose-determining mechanism 232 may also act between the dose selector member 310 and the dose setting member 290 via additional elements located between them. Such additional elements may be, for example, a clutch member 270 and / or a dosing member 330.

[0126] As can also be seen from Figure 12, the dose setting mechanism 232 comprises at least one corresponding functional feature portion 312 and, exemplary, at least one element 292 that engages with one of the teeth, when the dose setting member 290 reaches a rotational position relative to the housing 210 corresponding to each dose defined by the functional feature portion 312. At this time, the engagement between the element 292 and the functional feature portion 312 provides auditory and / or tactile feedback to the user of the drug delivery device 200. As can be seen from Figure 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 element 292 and functional feature portion 312 is configured as a flexible element that is radially deflected by engagement between element 292 and functional feature portion 312. According to the drug delivery device 200, element 292 is configured as such a flexible element. Additionally or alternatively, according to other embodiments of the dose-determining mechanism 232, the functional feature portion 312 may also be configured as a flexible element.

[0128] The functional feature portion 312 constitutes the dose stopping portion of the drug delivery device 200. The teeth provide several functional feature portions 312 that are circumferentially distributed around the longitudinal axis 207 to define multiple configurable doses. The functional feature portions 312 form rigid elements of the dose setting mechanism 232, which interact with a flexible element formed by element 292. Element 292 interacts with the functional feature portions 312 by resting on them during dose setting. Thus, the flexible element, exemplary, formed by element 292, bends radially.

[0129] According to each individual functional feature section 312, the drug delivery device 200 comprises at least one element involved in performing two functions of the administration mechanism 230. As a component of the clutch mechanism 234, the element constitutes a clutch element that plays a role in rotatably securing the nut 250 and / or dose setting member 290 to the piston rod 240 and / or housing 210. As a component of the dose setting mechanism, the element constitutes a dose stop section that defines the rotational position of the administration member 330 and / or dose setting member 290 relative to the housing 210. According to other embodiments of the drug delivery device 200, the functional feature section 312 may act only as a dose stop section and not as a clutch element, or may act only as a clutch element and not as a dose stop section. 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 section 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 feature portions 312 and the individual elements 292 are selected so that all elements 292 engage with their respective functional feature portions 312 at each rotational position of the dose-setting member 290 relative to the housing 210, corresponding to the configurable dose. Other embodiments of the drug delivery device 200 may also comprise other numbers of elements 292, for example, a single element 292.

[0131] According to the drug delivery device 200, the functional feature portion 312 may be located on the inner surface of the dose selector member 310, and the element 292 may be located on the outer surface of the dose setting member 290. Furthermore, the element 292 and three further elements 292 constitute a flexible arm. These elements 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 portion 312 has a flat side that engages with the corresponding flat side of the element 292. Furthermore, the clutch element 294 also has a flat side that engages with the flat side of the functional feature portion 312. If this applies to the drug delivery device 200, the flat sides of the functional feature portion 312 and / or the clutch element 294 and / or the element 292 may include a longitudinal axis 207 and be angled with respect to a radial plane intersecting the flat sides of the respective functional feature portion 312 and / or the clutch element 294 and / or the element 292.

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

[0134] The dose-determining 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 achieved, exemplary, by preventing relative rotation between two members that provide the dose-determining mechanism 232, namely, the dose setting member 290 and the dose selector member 310.

[0135] Figure 14 shows a radial cross-section through a 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, corresponding to the settable doses. To ensure precise rotational position 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 within the dose setting member 290, the opening 296 receiving the non-circular, i.e., rectangular distal portion 275 of the clutch member 270. The coding feature includes a first longitudinal ridge 279 and a second longitudinal ridge 280, the longitudinal ridges 279, 280 extending radially from opposing sides of the distal portion 275 of the clutch member 270. The first ridge 279 is received in a corresponding first longitudinal groove 297 located within the opening 296 of the dose setting member 290, and the second ridge 280 is received in a corresponding second longitudinal groove 298 of the dose setting member 290. The first ridge 279 and the first groove 297 have different dimensions, particularly width, than the respective dimensions, particularly width, of the second ridge 280 and the second groove 298. According to other embodiments of the drug delivery device 200, the coding features of the connection 277 may also be realized in a different manner, for example, by a ridge provided on the dose setting member 290 and a corresponding groove provided on the clutch member 270.

[0138] To permanently and irrevocably 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 Figures 15 and 16, this snap-fit ​​connection 277 includes two flexible snap hooks 278 located on opposing sides of the distal portion 275 of the clutch member 270. When the distal portion 275 is inserted into the opening 296 of the dose-setting member 290, the snap hooks 278 engage with corresponding recesses 295 provided within the sides of the opening 296. According to other embodiments, the irrevocable 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, the axial position of the dispensing member 330 corresponding to the minimum and maximum configurable doses is determined by the interaction between the dispensing member 330 and the inner housing 180. Therefore, the connection between the dose selector member 310 and the inner housing 180 is configured such that these axial positions correspond to the configurable doses defined by the dose setting mechanism 232.

[0140] According to the drug delivery device 200, such connection shown in Figure 14 is achieved by restricting 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 dimensions, particularly width, that are different from the corresponding dimensions, particularly width, of at least one, particularly three further longitudinal ridges 316 distributed over the remaining outer surface of the dose selector member 310. The further longitudinal ridges 316 are distributed over the remaining inner surface of the inner housing 180 and engage with corresponding further longitudinal grooves 188 having corresponding widths 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, particularly width, from 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] Figure 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 rotates relative to the nut 250, while simultaneously allowing relative axial movement. direction To lock, it has a longitudinal ridge 271 that engages with the longitudinal groove 254 of the nut 250. Generally speaking, the longitudinal ridge 271 and the corresponding longitudinal groove 254 form a spline connection between the clutch member 270 and the nut 250. According to another embodiment, rotation between the clutch member 270 and the nut 250 directionThe connection, which is fixed and axially movable, may also be achieved by other means, for example, by longitudinal ridges provided on the nut 250 and corresponding grooves provided on the clutch member 270.

[0143] Figure 18 shows a longitudinal cross-section of the drug delivery device 200 through the dispensing member 330 and the dose setting member 310. The drug delivery device 200 includes a friction reduction mechanism that operates between the dispensing member 330 and the dose selector member 310. The friction reduction mechanism is configured to reduce friction during relative rotational movement between the dispensing member 330 and the dose selector member 310.

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

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

[0146] The ball bearing 370 includes several 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 administration member 330. Furthermore, the ball bearing 370 includes a holder 372 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 administration member 330 that is configured to restrict movement between the dose selector member 310 and the administration member 330 in the axial direction, while allowing relative rotation between the dose selector member 310 and the administration member 330. Distal movement of the dose selector member 310 relative to the administration member 330 is hindered by a snap-fit ​​connection. The snap-fit ​​connection includes a circumferential annular ridge 344 on the outer surface of the administration member 330, and at least one, i.e., four, flexible members 319 formed on the dose selector member 310. When the dose selector member 310 is moved proximal over the administration member 330 during assembly, the flexible members 319 snap into place on the annular ridge 344 and engage with the proximal front surface 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 the flexible member of the administration member 330 engaging with the annular ridge of the dose selector member 310. Proximal movement of the dose selector member 310 relative to the administration member 330 is hindered by the contact surface 314 of the dose selector member 310 leaning against the distal end face 346 of the administration 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 ways. 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] Figure 19 shows a perspective view of the connection 354 between the nut 250 and the driver 350 of the drug delivery device 200. The connection 354 is configured to restrain the driver 350 relative to the nut 250 in the axial direction, and to allow relative rotational movement between the nut 250 and the driver 350.

[0150] The connection 354 is formed at the distal end of the driver 350 and comprises two flexible arms 356 that project radially inward and engage with an annular detent 255 between the proximal portion 251 and the distal portion 252 of the nut 250. When the driver 350 is moved distally relative to the nut 250, the flexible arms 356 abut against the distal side surface of the annular detent 255. A gap is provided between the distal side surface and the flexible arms 356 to allow the nut 250 and the driver 350 to advance distally by different distances during dose setting.

[0151] The drug delivery device 200 includes a further friction reduction mechanism configured to reduce friction between the nut 250 and the driver 350 during relative rotational motion relative to each other during dose delivery. The further friction reduction 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 the proximal front surface 358 of the driver 350 and the projection 253 located proximal to the nut 250. The proximal projection 253 defines a rim that extends radially from the nut 250. When the driver 350 rotates into the inner sleeve 183 of the inner housing 180 during dose delivery, the proximal front surface 358 of the driver 350 pushes the projection 253 via the additional bearing element 380, thereby pushing the nut 250 proximal as well.

[0153] The bearing element 380 is configured as a bearing disc 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, such as 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, that is, by transmitting axial force to the nut 250 via one or more intermediate members, i.e., bearing elements 380.

[0155] The piston rod 240 rotates relative to the housing 210 at least during dose delivery. direction The nuts 350 and piston rod 240 are fixed in place and rotate relative to each other during dose delivery. direction The nuts 250 and piston rods 240 are fixed in place, and as a result, the threaded connections 241 and 256 between the nuts 250 and piston rods 240 axially lock the nuts 250 relative to the piston rods 240 during dose delivery. Thus, the nuts 250 and piston rods 240 are configured to move simultaneously axially as if they were a single unit during dose delivery.

[0156] During dose setting, the nut 250 is configured to rotate relative to the piston rod 240. Thus, the piston rod 240 is also locked to rotate relative to the housing 210 during dose setting, and the nut 250 is configured to rotate relative to the housing 210 during dose setting. At this time, due to the threaded connections 241, 256 between the nut 250 and the piston rod 240, the rotation of the nut 250 during dose setting causes the nut 250 to advance axially relative to the piston rod 240. At this time, the axial advance of the nut 250 relative to the piston rod 240 and / or housing 210 also stipulates the axial advance of the piston rod 240 relative to the housing 210 during dose delivery.

[0157] Figure 20 shows a perspective view of the administration member 330 of the drug delivery device 200. The administration member 330 includes a maximum dose stop 337 configured to engage with the inner housing 180 upon setting of the maximum dose. Thus, the engagement of the maximum dose stop 337 with the inner housing 180 restricts further axial movement of the administration member 330 in the distal direction, defining the axial and rotational positions of the administration member 330 corresponding to the maximum dose that can be set by the administration mechanism 230.

[0158] As can be seen from Figure 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 stopping feature portion 190, i.e., four maximum stopping feature portions 190. The maximum stopping feature portions 190 are formed as integral parts of the inner housing 180. Each maximum stopping feature portion comprises a flexible hook 191 that projects radially inward into the housing cavity 189 of the inner housing 180 that receives the dosing member 330. Each flexible hook 191 is oriented perpendicular to the longitudinal axis 207 and comprises a limiting surface 192 facing proximal.

[0159] When the administration member 330 is inserted into the housing cavity 189, the flexible hook 191 snaps onto the maximum dose stop 337, thereby restricting the distal axial movement of the administration member 330. When the maximum dose is set, the distal stop surface 338 of the maximum dose stop 337 contacts 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 stopper 337 and is oriented perpendicular to the longitudinal axis 207.

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

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

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

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

[0164] The dispensing member 330 is configured to perform two complete rotations around the longitudinal axis 207 when moving from the zero dose position to the maximum dose position. At 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 at 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 fewer or more rotations than two full rotations around 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 one full rotation or a non-integer rotation that deviates from an integer multiple of one full rotation. Similarly, the maximum dose marker may indicate any other dose that deviates from the set dose in 5.4, for example, a set dose of 1.8 or 3.6.

[0166] The maximum stopping feature portion 190 projecting inward from the inner housing 180 is located inside the longitudinal detent 320 of the dose selector member 310. This allows the limiting surface 192 to engage with the stopping surface 338 of the administration member 330, except for the dose selector member 310 that surrounds the administration member 330 at its distal portion 333.

[0167] The inner housing 180 is locked to the outer housing 211 with respect to both axial and rotational movement. As can be seen from Figures 22 and 23, the inner housing 180 includes projections 194 distributed circumferentially around the outer surface of the distal portion 182 of the inner housing 180. Furthermore, the inner housing 180 includes radial projections 195 located on the outer surface of the proximal portion 181 of the inner housing 180. According to the embodiments shown in Figures 22 and 23, the two radial projections 195 are arranged adjacent to each other, parallel to the longitudinal axis 207. Both projections 195 are located at the same circumferential position on the outer surface of the inner housing 180.

[0168] As can be seen from Figure 24, which shows a longitudinal cross-section through the outer housing 211 of the drug delivery device 200, the outer housing 211 has a circumferential groove 218 located within the distal portion of the outer housing 211 on its inner surface. Furthermore, the outer housing 211 has a detent 216 within the proximal portion of its inner surface.

[0169] Figure 25 shows a longitudinal cross-section of the inner housing 180 mounted within the outer housing 211 of the drug delivery device 200. A projection 194 within the distal portion 182 of the inner housing 180 is configured to prevent axial movement of the inner housing 180 relative to the outer housing 211 in the distal direction. These projections snap into the circumferential groove 218 when the inner housing 180 is mounted inside the outer housing 211 by inserting it distally. When the inner housing 180 is pushed distally after full insertion, the projections 194 engage with the distal end face of the circumferential groove 218, thereby preventing axial movement. Proximal, the inner housing 180 abuts against a step within the inner surface of the outer housing 211, which restricts the proximal movement of the inner housing.

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

[0171] The radial projections 195 within the proximal portion of the inner housing 180 are configured to prevent rotational movement of the inner housing 180 relative to the outer housing 211. These projections engage with a detent 216 within the proximal portion of the inner surface of the outer housing 211. This is further illustrated in Figure 26, which shows a radial cross-section of the drug delivery device 200 through the outer housing 211 and inner housing 180 through line AA shown in Figure 25. According to other embodiments of the drug delivery device 200, the 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 have projections that engage with a detent located on the outer surface of the inner housing 180.

[0172] Following the assembly of the drug delivery device 200, the dose selector member 310 and the administration member 330 are first assembled together and inserted into the inner housing 180. The inner housing 180 is then inserted into the outer housing 211 only afterward. After being inserted into the outer housing 211, the flexible hook 191 rests against the inner surface of the outer housing 211, thus preventing outward bending of the flexible hook 191. This prevents the hook 191 from disengaging from the maximum dose stop 337 upon setting the maximum dose.

[0173] With all drug delivery devices according to this disclosure, the design of each maximum dose stop unit 337 and zero dose stop unit 340 is generally independent of the design of the rest of the device, in particular the details of the rotatable coupling between each dose setting member and each dose sleeve, each clutch mechanism, dose setting mechanism, reset mechanism, 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 the user to replace an empty cartridge 8 with a new one after the last dose has been delivered from a given cartridge 8.

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

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

[0177] According to this disclosure, the housing 210 comprises all members that are rotatable during the intended use of the drug delivery device 200 and permanently fixed to the outer housing 211 in the axial direction. 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 therefore also between the housing 210 and the reset element 110. The biasing element 150 biases the reset element 110 in the proximal direction toward a position proximal to the housing 210 and the coupling portion 130.

[0179] Figure 28 shows a longitudinal cross-section of the drug delivery device 200 through the reset mechanism 100, with the reset element 110 in a proximal position. In this configuration, the reset element 110 is movable with respect to rotation relative to the housing 210. The reset element 110 has a gripping zone 111 at its proximal end, which can be gripped by the 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] Rotation between reset element 110 and piston rod 240 directionDue to the connection fixed to the reset element 110, when the user rotates the reset element 110, the piston rod 240 is forced to rotate together with the reset element 110. Then, the engagement between the threads 241 of the piston rod 240 and the threads 256 of the nut 250, in response to the rotation of the reset element 110 in the reset direction, forces the piston rod 240 to advance distally and return into the housing 210. Thus, the reset element 110 is configured to move the piston rod 240 back into the housing 210 in response to rotation by the user.

[0181] Generally, the piston rod 240 is screw-engaged with a component of the dose setting mechanism 230, namely a nut 250, and the reset element 110 rotates relative to this component during the reset of the piston rod 240. When this applies exemplary to a drug delivery device 200, the component 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 rotate relative to the housing 210 in response to the reset of the piston rod 240.

[0182] Furthermore, the piston rod 250 rotates relative to the reset element 110, at least during the reset operation. direction It is fixed to the reset element 110 and is axially movable. According to the drug delivery device 200, the piston rod 250 rotates relative to the reset element 110. direction It is permanently fixed in place. Furthermore, the piston rod is permanently movable axially 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 the user of the device 200. The connection 354, which axially restrains the driver 350 against the nut 250, serves to prevent undesirable movement of the piston rod 240, which could be caused by the piston rod 240 being pushed or pulled directly by the user without the reset element 110 rotating simultaneously.

[0184] For example, if the user sets the dosage while the cartridge holder 412 is removed from the housing 210, both the nut 250 and the driver 350 will move distally. Without the connection 354, the nut 250 would not be prevented from moving proximal again if the user subsequently pulls the piston rod 240, allowing the user to pull the piston rod 240 out of the housing 210. This could give 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 rotating simultaneously. 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 the gearing or mechanical advantages caused by the different pitches of the threaded connection 352 between the driver 350 and the inner housing 180, and the threaded connection 334 between the dosing member 330 and the inner housing 180, the force that can typically be exerted by the user by pulling or pushing the piston rod 240 is not large enough to overcome the resistance required to cause rotation of the dosing member 330, clutch member 270 and dose setting member 290 by directly forcing the driver 350 to rotate. Therefore, when the dose setting member 290 is not activated, the driver 350, and the nut 250 via the connection 354, are essentially rotatable and locked in the axial direction.

[0186] Figure 29 shows a distal oblique view of the reset element 110, Figure 30 shows a proximal oblique view of the reset element 110, and Figure 31 shows a proximal oblique view of the connecting portion 130 of the reset mechanism 110.

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

[0188] As can also be seen from Figure 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, so that the annular notch 136 is received within a corresponding collar 213 on the inner surface of the outer housing 211. The notch 136 is restricted distally 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 into place on the annular collar 213 of the outer housing 211. In this way, 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 hindered by other means, for example, by a notch located on the housing 210 and a collar or projection located on the coupling portion 130.

[0189] To rotatably lock the coupling portion 130 relative to the housing 210, the coupling portion 130 includes a projection 138 located within a notch 136. The projection 138 engages with a corresponding detent 214 in the annular collar 213. These detents 214 are shown, in particular, in Figure 24. According to other embodiments, rotation between the coupling portion 130 and the housing 210 may also be prevented by other means, for example, by a projection provided on the housing 210 and a corresponding detent provided on the coupling portion 130.

[0190] The locking structure 137 of the coupling portion 130 comprises two parts separated by a longitudinal slot 139. This allows those parts of the locking structure 137 to bend radially inward when the coupling portion 130 is mounted on the outer housing 211. After the coupling portion 130 is mounted and the inner housing 180 is mounted on the outer housing 211, those parts of the locking structure 137 are prevented from bending 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 joint portion 130 and the inner housing 180. The inner housing 180 has two longitudinally projecting tappets 184 on its front surface, as can also be seen, for example, in Figure 23. The tappets 184 are received in longitudinal slots 139, thereby preventing the aforementioned portion of the locking structure 137 from bending radially inward.

[0192] Figure 33 shows a longitudinal cross-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 on a step formed on the outer surface of the outer housing 211.

[0193] While the distribution unit 410 is being mounted, the reset element 110 is moved distally to its distal position, and the reset element 110 is rotatably locked to the housing 210. When in the distal position, the engaging feature portion 120 of the reset element 110 engages with the corresponding engaging feature portion 135 of the coupling portion 130, thereby rotatably locking the reset element 110 to the coupling portion 130 and the housing 210.

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

[0195] In the embodiments shown in Figures 27 to 33, the engaging features 120 and 135 are configured as symmetrical teeth having circumferential sides with the same gradient. According to other embodiments, the teeth of the engaging features 120 and 135 may also be configured as asymmetrical teeth. For example, asymmetrical teeth may have circumferential sides with different gradients. Thus, one side of each tooth may be oriented parallel to the longitudinal axis 207, for example, and the other side of each tooth may be tilted with respect to the longitudinal axis 207. Such asymmetrical teeth can provide, for example, a serrated profile.

[0196] With the asymmetrical engagement features 120, 135, the sides of each engagement feature 120, 135 having a steeper slope than the other side may be configured to push 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 reverse rotation of the piston rod 240 relative to the nut 250 when the dose setting member 290 and the nut 250 have swung too far after the threads 256 of the nut 250 engage with the stop feature 243 of the piston rod 240 in response to an increase in dose during dose delivery or dose setting.

[0197] As can be seen from Figure 33, upon mounting the distribution unit 410 onto the housing 210, the cartridge holder 412 of the distribution unit 410 directly engages with the reset element 110 in order to push the reset element 110 distally. Thus, the proximal contact structure 117 of the reset element 110 leans against the distal contact feature portion 450 of the cartridge holder 412. The proximal contact structure 117 is exemplary configured as the proximal circumferential edge portion of the reset member 110. The distal contact feature portion 450 is exemplary provided as a distally 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 lock distance between the reset position and the locked position may be less than, for example, 2 mm, 1.5 mm, 1.25 mm, 1.1 mm, or 1 mm, and / or greater 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] As the cartridge holder 412 is mounted on the housing 210, the cartridge 8 does not come into contact with the reset element 110. Therefore, 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, and the cartridge cavity 115 is accessible from the 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 their longitudinal extension range than individual cartridge holders 412, which are typically made from plastic material. Therefore, the engagement features 120, 135 need to have relatively large axial heights to provide a secure lock with respect to rotation between the reset element 110 and the coupling portion 130, regardless of the possible variation in the length of individual cartridges 8 due to manufacturing tolerances.

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

[0202] Figure 34 shows a longitudinal section through the proximal end of a cartridge holder 412, which is attachable to a drug delivery device 200, with the cartridge 8 inserted into the cartridge holder 412. Figure 35 shows a distal perspective view of a radial section through the proximal portion of the cartridge holder 412 along line BB in Figure 34. Inside the cartridge holder 412, the cartridge 8 is pushed against the stop portion 408 by a biasing element 406. The biasing element 406 engages with the distal surface 83 of the annular rim 82 of the cartridge 8. Thus, the biasing element engages with the 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 provided within the outer wall of the cartridge holder 412.

[0203] The outer wall of the cartridge holder 412 surrounds the cartridge cavity 413, which 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 greater than the longitudinal extension of the cartridge 8. This prevents a user of the distribution unit 410 from touching or grasping the cartridge 8 and removing the cartridge from the cartridge holder 412.

[0204] As can be seen from Figure 34, the cartridge holder 412 comprises both a biasing element 406 and a connector 404, which 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 in the same longitudinal position.

[0205] Thus, the biasing element 406 biases the cartridge 8 proximal toward the stop 408, and is configured to bias it permanently. The cartridge 8 is clamped between the stop 408 and the biasing element 406, so that both the stop 408 and the biasing element 406 lean against the cartridge 8 simultaneously. The biasing element 406 prevents the movement of the cartridge 8 within the cartridge holder 412. For example, when the needle 4 is mounted in the cartridge holder 412, the biasing element 406 biases the cartridge 8 proximal toward the hollow cannula 6.

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

[0207] The contact surface 405 engages with the 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 in particular, perpendicular to the longitudinal axis 207. The opposing surface is provided, exemplary, by the distal surface 83 of the annular rim 82 of the cartridge 8.

[0208] The connector 404 is configured to deflect toward the longitudinal axis 207 when the cartridge 8 engages with the connector 404 in response to an attempt to remove the cartridge 8 from the cartridge holder 412. This further prevents the cartridge 8 from being removed from the cartridge holder 412 by locking it inside the cartridge holder 412.

[0209] According to the cartridge holder 412, the contact surface 405 has an angle with respect to the longitudinal axis 207 that is larger than that of the opposing surface 83. When the cartridge 8 moves distally and makes contact with the opposing surface 83 of the cartridge 8, the connector 404 bends so that its contact surface 405 is parallel to the opposing surface 83. This causes the connector 404 to be radially deflected 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 then no longer contacts the contact surface 405. The action of the biasing element 406 biases the cartridge 8 to its fully inserted position.

[0211] The clamped end of connector 404 is connected to the body of cartridge holder 412, and the free end of connector 404 is configured separately from the body of cartridge holder 412. According to connector 404, the free end is located at the proximal end of connector 404, and the clamped end is located at the distal end of connector 404. Connector 404 is configured as a flexible member. Thus, the free end of connector 404 can be deflected radially. When cartridge 8 is inserted into cartridge holder 412, cartridge 8 first deflects connector 404 radially outward from the longitudinal axis 207. As cartridge 8 moves further proximal, connector 404 then snaps onto cartridge 8, i.e., onto the annular rim 82 of 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. As the cartridge 8 moves further proximal, 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, the contact surface 407 of the biasing element 406 rests on the cartridge 8 and is configured to exert a biasing force in the proximal direction. This contact surface 407 has an angle with the longitudinal axis 207 that is smaller than the angle with the longitudinal axis 207 of the contact surface 405 of the connector 404.

[0214] The biasing element 406 is configured to bend radially outward from the longitudinal axis 207 and the cartridge 8 in response to an attempt to remove the cartridge 8 from the cartridge holder 412. According to the cartridge holder 412, the contact surface 407 of the biasing element 406 has an angle with respect to the longitudinal axis 207 that is larger than the opposing surface 83 of the cartridge 8.

[0215] The cartridge holder 412 serves two functions. Firstly, the cartridge holder prevents the user from removing the cartridge 8 from the cartridge holder 412 without the use of tools. Secondly, the cartridge holder prevents the cartridge 8 from moving axially when the user attaches the needle 4 to the needle connector 402.

[0216] The first function is achieved by a connector 404 that securely snaps into place after the cartridge 8 is inserted. This is achieved, exemplary, by a connector 404 that has some clearance from the distal surface 83 of the cartridge 8 after insertion. The distance between the stop 408 and the connector 404 is adapted to accommodate varying thicknesses of the annular rim 82 of the cartridge 8. Thus, this distance is adapted to various positions on 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 snap into place radially even when a cartridge 8 with an axially long annular rim 82 is inserted.

[0217] According to the cartridge holder 412, the body of the cartridge 8 is not held at its distal end (see Figure 8). Without the biasing element 406, the cartridge 8 would be pushed proximal only by the plunger disc 242 that contacts the piston 9 of the cartridge 8. When the user installs a new needle 4, the cannula 6 pushes the cartridge 8 distally, causing the plunger disc 242 and piston rod 240 to push the piston 9 proximal to the body of the cartridge 8. When the cannula 6 punctures the septum, the pressure on the piston 9 could result in drug loss. To avoid this drug loss, the axial movement of the cartridge 8 during the loading of the needle 4 into the cartridge holder 412 and / or during the puncture of the septum of the cartridge 8 by the cannula 6 is prevented by the biasing element 406.

[0218] The biasing element 406 is adapted to compensate for dimensional tolerances of the annular rim 82 of the cartridge 8, such as tolerances of its axial length and / or diameter. This is achieved, exemplary, by configuring the biasing element 406 to lean against the cartridge 8 after full insertion, and / or by configuring the biasing element 406 to bend radially outward in response to distal movement of the cartridge 8 after insertion.

[0219] The connector 404 does not bias the cartridge 8 proximal after insertion, but allows slight axial movement. The biasing element 406 is configured to exert a force on the cartridge 8 that resists its movement during the attachment of the needle 4. This force may act in addition to the frictional force acting on the cartridge 8 after the cartridge holder 412 is inserted into and / or attached to the drug delivery device 200. Thus, the biasing element 406 does not completely inhibit the distal axial movement of the cartridge 8 after insertion. For example, the 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 having a cartridge holder 412 permanently and inseparably connected to a housing 210. Thus, the cartridge holder 412 cannot be disconnected from the housing 210 during the intended use of the device 200 and / or without damaging the device 200. For example, these embodiments may have a cartridge holder 412 that in this case features only a biasing element 406 and does not feature a connector 404.

[0221] The drug delivery device 200 is a reusable device that allows the used cartridge holder 412 to be removed and a new cartridge holder 412 to be reattached. As detailed below, the drug delivery device 200 is also provided in different versions adapted to deliver drugs of at least different concentrations. Different drugs are provided in cartridges 8 which are inserted into dedicated cartridge holders 412. Furthermore, the connecting means 510 of each version of the drug delivery device 200 and the connecting means 412 of each version of the cartridge holder 412 are configured as keyed connectors. Thus, the connecting means 510 of each individual version of the drug delivery device 200 connects only to the connecting means 414 of the specific version of the cartridge holder 412 that will hold the drug to be delivered by that drug delivery device 200, and not to the connecting means 414 of other versions of the cartridge holder 412.

[0222] In this case, the connector 404, which prevents the removal of cartridge 8 from its cartridge holder 412, increases safety during use of the device 200 and 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 the user's drug delivery device 200 due to the keying features of the connecting means 414, 510. The connector 404 then prevents the user from removing the cartridge 8 holding the wrong drug from its version of the cartridge holder 412 and inserting those cartridges into a cartridge holder 412 that is fitted to the version of the drug delivery device 200 used by the user, and thus from using cartridge 8 with the wrong version of the drug delivery device 200 and / or using cartridge 8 holding the wrong drug.

[0223] Other embodiments of the cartridge holder 412 may include only the biasing element 406 and omit the connector 404, or may include only the connector 404 and omit the biasing element 406.

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

[0225] According to this disclosure, the drug delivery device 200 may be part of a set of several drug delivery devices, and the distribution unit 410 may be part of a set of several distribution units, so that each drug delivery device is configured to be attached only to a dedicated distribution unit and not to be attached to any other distribution units in the set, and vice versa. Thus, the connection means is configured as a keyed connection means, providing a one-to-one assignment between individual distribution units and individual drug delivery devices.

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

[0227] Figures 36 and 37 illustrate sets of three drug delivery devices and three corresponding distribution units according to the present disclosure. Each drug delivery device is connected to its corresponding distribution unit by a keyed connection that prevents each drug delivery device from connecting to other distribution units, and conversely, prevents the corresponding distribution unit from connecting to other drug delivery devices.

[0228] Figure 36 shows a longitudinal cross-section through the first dispensing unit 420, which is attachable to the first housing 221 of the first drug delivery device 220 via the first connecting means 424 of the first cartridge holder 422; a longitudinal cross-section through the second dispensing unit 430, which is attachable to the second housing 223 of the second drug delivery device 222 via the second connecting means 434 of the second cartridge holder 432; and a longitudinal cross-section through the third dispensing unit 440, which is attachable to the third housing 226 of the third drug delivery device 225 via the third connecting means 444 of the third cartridge holder 442. Figure 37 shows side and perspective 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 holders 422, 432, 442 and the corresponding connecting means 511, 520, 530 of the drug delivery devices 220, 222, 225 form the keyed connector according to this disclosure. Thus, 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] Each of the connecting means 424, 434, and 444 of the cartridge holders 422, 432, and 442 forms the female part of the connection, and each of the connecting means 511, 520, and 530 of the drug delivery devices 220, 222, and 225 forms the corresponding male part. All of the connecting means 424, 434, 444, 511, 520, and 530 are configured as screw threads, so that the connecting means 424, 434, and 444 of the cartridge holders 422, 432, and 442 form internal screw threads, and the connecting means 511, 520, and 530 of the drug delivery devices 220, 222, and 225 form external screw threads.

[0231] The geometry of threads 424, 434, 444, 511, 520, and 530 is defined by several thread dimensions. These thread dimensions include the core diameter or small diameter specifying the minimum inner diameter of the female portion of the connection, the outer diameter or large diameter specifying the maximum inner diameter of the female portion of the connection, the pitch specifying the distance between adjacent ridges 501 or valleys 502 of the thread, the width of the ridges 501 on the male portion of the thread corresponding to the width of the valleys 502 on the female portion of the thread, the opening angle between the side walls of adjacent ridges 501 on the male portion, and the height of the ridges 501 on the male portion, given by the difference between the outer diameter and the core diameter, and the corresponding height of the valleys 502 on the female portion.

[0232] Unless otherwise stated, the term “ridge” as used in this disclosure always refers to the ridge 501 of the male thread of a given screw connection, regardless of whether the described portion actually contains male or female threads. These ridges may also be referred to as the apex of the screw connection. The corresponding valley of the female thread may also be referred to as the root of the screw connection.

[0233] Keying is achieved by at least one of the thread dimensions, such as core diameter, outer diameter, pitch, width of the ridge portion 501 and opening angle, which differ from each other between individual pairs of the corresponding connecting means 424, 434, 444, 511, 520, 530 of the cartridge holders 422, 432, 442 and the drug delivery devices 220, 222, 225, respectively.

[0234] According to the embodiments shown in Figures 36 and 37, the only thread dimensions that differ between the individual distribution units 420, 430, and 440, and therefore also between the individual drug delivery devices 220, 222, and 225, are the width and height of the individual ridges 501 of the male portion, as well as the corresponding width and height of the valleys 502 of the female portion. Thus, the ridge 501 of the first connecting means 511 has a first width w1, the ridge 501 of the second connecting means 520 has a second width w2, and the ridge 501 of the third connecting means 530 has 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 raised portion 501 of the first connecting means 511 has a first height h1, the raised portion 501 of the second connecting means 520 has a second height h2, and the raised portion 501 of the third connecting means 530 has 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 height h1, h2, and h3, combined with the aforementioned differences in width w1, w2, and w3, reliably prevent the individual distribution units 420, 430, and 440 from being mounted on drug delivery devices other than their corresponding drug delivery devices 220, 222, and 225, which have matching connecting means 511, 520, and 530.

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

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

[0239] According to the embodiments 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 embodiments shown in Figures 36 and 37, the individual thread dimensions may be as follows: CD1=CD2=CD3=12.60mm, D1=14.70mm, D2=14.00mm, D3=13.30mm, h1=2.10mm, h2=1.40mm, h3=0.70mm, w1=0.65mm, w2=1.30mm, w3=1.95mm, and A1=A2=A3=60°. Thus, the pitch of each individual thread may all be P1=P2=P3=3.80mm.

[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, and A1=A2=A3=60°. The pitch of each individual thread may all be P1=P2=P3=3.80mm.

[0242] Alternatively, the aforementioned dimension of the width w of the ridge portion of the male thread may be applied to the width g of the male thread valley instead of the width w of the ridge portion of the male thread. Thus, the width g of each male thread valley may be defined as the bottom section of the male thread groove that is located in the core diameter and extends between the angled sides that demarcate the ridge portion of the male thread, as shown in Figures 58 and 59.

[0243] In this case, the thread dimensions may 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, g1=1.95mm, g2=1.30mm, g3=0.65mm, A1=A2=A3=60°, and P1=P2=P3=3.80mm. According to this embodiment, the width w of the raised portion of the male thread may be w1=1.84mm, w2=2.50mm, and w3=3.15mm. Thus, the width w of the raised portion is defined as the width including the top surface that defines the outer diameter D and the angled side surfaces that connect each top surface to the adjacent valley. Therefore, the width w is w=Pg. These dimensions are shown in Figure 58, which shows distribution units 420, 430, and 440, and in Figure 59, which shows the corresponding connection means 511, 520, and 530 for distribution units 220, 222, and 225.

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

[0245] Alternatively, the aforementioned relationship may be applied similarly to the width g of the valley of the male thread instead of the width w of the ridge portion of the male thread. Thus, the first device may have a thread with a valley having a width g that is N times the width g of the valley of the thread of the Nth device, and the first device may have a thread with a ridge having a height that is N times the height of the ridge portion of the Nth device. In this case, the mth device (where 1 ≤ m ≤ N) may have a thread with a valley having a width that is (N-m+1) times the width g of the valley of the thread of the Nth device, and a height that is (N-m+1) times the height of the ridge portion of the thread 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 variant of the drug delivery device 200 disclosed in connection with FIGS. 1-35. Unless otherwise noted or not 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 at this time, and vice versa. Further, the first dispensing unit 420, the second dispensing unit 430, and the third dispensing unit 440 are each a variant of the dispensing unit 410 disclosed in connection with FIGS. 1-35. Unless otherwise noted or not apparent from the figures, the first dispensing unit 420, the second dispensing unit 430, and the third dispensing unit 440 are configured as disclosed in connection with the dispensing unit 410 at this time, and vice versa.

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

[0248] The second drug delivery device 222 and the first drug delivery device 220 each include at least one distinguishing member that is different 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 include at least one additional distinguishing member that is different between the first drug delivery device 220 and the third drug delivery device 225. Thus, the distinguishing member and the additional distinguishing member are the same functional members and thus perform the same function during use of the dosing mechanism. According to other embodiments, the interacting members and the additional interacting members may also be different functional members.

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

[0250] The functional members constitute the individual parts of which the drug delivery devices 220, 225, 225 are assembled. The individual parts may have different exact shapes and appearances, for example, to provide different dose increments between the individual drug delivery devices 220, 225, 225, but those parts perform the same function and are located in the same position within the dosing mechanisms 230 of the individual drug delivery devices 220, 225, 225. Further, those parts interact and engage with the same additional functional members of the dosing mechanism 230 between all drug delivery devices 220, 225, 225 of the set. The functional members may be composed of several sub-parts that are rigidly connected to each other to form a single mechanical part. According to one embodiment of the present disclosure, the dosing member may constitute a functional member composed of, for example, two sub-parts, 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 mechanically distinct drug delivery devices only by their outer housings 221, 223 that carry keyed connecting means 510, 520. All other functional components of the first set of drug delivery devices 220, 222 are mechanically identical. Therefore, the administration mechanism 240, clutch mechanism 234, and dose setting mechanism 232 of the two drug delivery devices 220, 222 are also the same. Thus, the two drug delivery devices 220, 222 are configured to define the same rotational dose position of the dose setting member 290 and to eject the same amount of liquid per settable dose increment.

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

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

[0254] The administration members 330 of the two drug delivery devices 220 and 222 of the first set form distinguishing members that look different but have the same shape between the two drug delivery devices 220 and 222. Thus, the visual difference includes different numbers on the visual indicators 331, so that each indicator 331 is located in the same position on the administration members 330 of each of the two drug delivery devices 220 and 222.

[0255] The outer housings 211 of the two drug delivery devices 220, 222 of the first set form distinguishing elements with different shapes due to the differences in their connecting means 511, 520. Furthermore, the outer housings 211 have different appearances, such as color and / or labeling, to allow the user to clearly distinguish between the two devices 220, 222.

[0256] The dose selector members 310 and caps 209 of the two drug delivery devices 220, 222 of the first set also form distinguishing members that look different but have the same shape between the two drug delivery devices 220, 222. Thus, the visual difference includes different labeling on the dose selector members 310 and caps 209. Furthermore, the caps 209 are colored to match the color of the respective bodies of those drug delivery devices 220, 222. According to other embodiments, the dose selector members 310 and / or caps 209 may also be configured as reciprocal members. Furthermore, the caps 209 may also differ only in color, with the labels being the same 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, forms a second set of drug delivery devices 200, 220, and 225, in which not only their outer housings 211 but also the functional components of their administration mechanisms 230, in particular their dose-defining mechanisms 232, are mechanically different.

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

[0259] The dose selector member 310 of the third drug delivery device 225 comprises 18 functional feature portions 312 distributed across its inner surface. Thus, the position of the elastic element 292 of the dose setting member 290 is adapted to a greater distance between the individual functional feature portions 312 in order to enable reliable engagement between the elastic element 292 and the functional feature portions 312.

[0260] The dose setting mechanism 332 of the third drug delivery device 225 is configured such that, in order to define an even number of settable doses, the connection 277 between the clutch member 270 and the dose setting member 290 connects the clutch member 270 and the dose setting member 290 in two different relative rotation directions that are 180° apart from each other. To achieve this, the first longitudinal groove 297 and the second longitudinal groove 298 of the dose setting member 290 and the corresponding first ridge 279 and the second ridge 280 of the clutch member 270 each have the same width.

[0261] The clutch member 270 of the third drug delivery device 225 comprises 18 clutch elements 273 whose circumferential positions are matched to the circumferential positions of the functional feature portion 312 of the dose selector member 310. Therefore, 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 members 270 of the first drug delivery device 220 and the second drug delivery device 222 on one side, and the clutch member 270 of the third drug delivery device 225 on the other side, form distinguishing members with different shapes among the second set of drug delivery devices 220, 222, 222, and 225. Similarly, the dose setting members 290 of the first drug delivery device 220 and the second drug delivery device 222 on one side, and the dose setting member 290 of the third drug delivery device 225 on the other side, also form distinguishing members with different shapes among the second set of drug delivery devices 220, 222, and 225.

[0263] The administration member 330 of the third drug delivery device 225 comprises 18 clutch elements 336 whose circumferential positions are matched to the circumferential positions of the clutch elements 273 of the clutch member 270. Thus, the administration member 330 of the third drug delivery device 225, as well as the administration members 330 of the first drug delivery device 220 and the second drug delivery device 222, each form a distinguishing member with a different shape among the second set of drug delivery devices 220, 222, and 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 rotatably connect a nut 250 to the administration member 330 and / or housing 210 at the same relative rotational position. The clutch mechanism 234 of the first drug delivery device 220 and the second drug delivery device 222 on one side, and the clutch mechanism 234 of the third drug delivery device 225 on the other side, are configured to rotatably connect a nut 250 to the administration member 330 and / or housing 210 at 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 rotatably connect the dose setting member 290 to the administration member 330 and / or housing 210 at the same relative rotational position. The clutch mechanism 234 of the first drug delivery device 220 and the second drug delivery device 222 on one side, and the clutch mechanism 234 of the third drug delivery device 225 on the other side, are configured to rotatably connect the dose setting member 290 to the administration member 330 and / or housing 210 at different relative rotational positions.

[0266] According to all drug delivery devices 200, 220, 222, and 225, the clutch element 273 of the clutch member 270, the clutch element 336 of the administration 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 with each other so that, at each rotational position of the dose setting member 290, the clutch element 294 of the dose setting member 290 and the clutch element 312 of the dose selector member 310 are also rotatably aligned with each other so that they are alignable with each other and can engage with each other.

[0267] Furthermore, in order 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 administration member 330 of the third drug delivery device 225 is different from the position of the optical marker 331 on the administration members 330 of the first drug delivery device 220 and the second drug delivery device 222. Therefore, the administration member 330 of the third drug delivery device 225 looks different from the administration members 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 administration member 330 of the first drug delivery device 220 is different from the numbering of the individual optical markers 331 on the administration 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 the active pharmaceutical ingredient, and the third drug delivery device 225 to be used with a drug having a third concentration of the active pharmaceutical ingredient, thereby different the product of the first concentration having an amount of liquid ejected by the first drug delivery device 220 per dose increment from the product of the third concentration having 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 administration member 330 of the second drug delivery device 222 is equal to the numbering of the individual optical markers 331 on the administration 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 the active pharmaceutical ingredient, and the third drug delivery device 225 to be used with a drug having a third concentration of the active pharmaceutical ingredient, so that the product of the second concentration having an amount of liquid ejected by the second drug delivery device 222 per dose increment is equal to the product of the third concentration having an amount of liquid ejected by the third drug delivery device 225 per dose increment.

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

[0271] Generally, the mutual members of the second sets of drug delivery devices 220, 222, 225 are the piston rod 240, the plunger disk 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, namely, the reset element 110, the coupling portion 130, and the biasing member 150.

[0272] Differentiating members that have only different appearances but the same shape between the second sets of drug delivery devices 220, 222, 225 are the caps 209 each having a different color. Differentiating members that have different appearances and shapes between the second sets of drug delivery devices 220, 222, 225 are the outer housings 211 each having different colors and different connecting means 511, 520, 530, their optical markers 331 each having different positions and / or numbers and / or labelings, the dosing member 330 having different-shaped clutch elements 336, the dose selector member 310 having different labelings and different amounts of functional features 312, the clutch members 270 having different-shaped and / or different-numbered clutch elements 273 and thus different appearances, and the dose setting members 290 having different positions of their elastic elements 292 and their clutch elements 294 and thus different appearances.

[0273] The first drug delivery device 220 is configured for use with a drug containing a pharmacoactive ingredient at a concentration of 5 mg / 1.5 ml, the second drug delivery device 222 is configured for use with a drug containing a pharmacoactive ingredient at a concentration of 10 mg / 1.5 ml, and the third drug delivery device 225 is configured for use with a drug containing a pharmacoactive ingredient at 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 displays a dose increment of 0.05 mg, while the optical marker 331 on the dosing member 330 of the second drug delivery device 222 and the third drug delivery device 225 each displays a dose increment of 0.10 mg. All drug delivery devices 220, 222, and 225 allow for two full 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 the active pharmaceutical ingredient, and the second drug delivery device 222 is configured to eject a maximum dose of 3.60 mg of the active pharmaceutical ingredient. The third drug delivery device 225 is configured to deliver a maximum dose of 5.40 mg of the active pharmaceutical ingredient, providing 18 dose increments per rotation of the dose setting member 290.

[0275] The reset mechanism described herein is also applicable in conjunction with other drug delivery devices, such as injection devices. A further possible injection device is a pen-type additional drug delivery device 10 illustrated in Figures 38–40. Unless otherwise noted or evident from the figures, the additional drug delivery device 10 is configured as disclosed in relation to drug delivery device 200, and vice versa. The additional drug delivery device 10 is also described in more detail in International Publication No. 2020 / 015980 and International Publication No. 2019 / 011394, and each of these disclosures is incorporated in whole by reference into this disclosure.

[0276] A further drug delivery device 10 has an outer housing 3 connected to a distribution unit 410 having a cartridge holder 2 that holds a cartridge 8. The cartridge holder 2 has a needle connector 402. The infusion device 10 has a dosing mechanism 30 and is illustrated in a zero-dose state as indicated by an optical marker 40 indicating zero through a window 3a of the outer housing 3. The outer housing 3 terminates at its proximal end with a keyed connection means 510 having the form of a screw thread.

[0277] Figure 40 schematically shows a simplified exploded view of the device 10 with the cap 1 removed to expose the cartridge holder 2 and the proximal needle connector 402. The needle 4 is typically attached to the needle connector 402 through a snap fit, thread, Luer lock™, or other secure attachment with a hub 5, thereby enabling the double-ended needle cannula 6 to achieve fluid communication with the drug contained in the cartridge 8 located within the cartridge holder 2.

[0278] The specific design of device 10 allows setting one or more of a predetermined fixed dose through the interaction of the snap element 33 with the dose selector member 35. The rotation of the dose setting member 31 and the snap element 33 occurs during dose setting and is relative to the outer housing 3. At the start of the dose delivery procedure, the dose setting member 31 is pushed proximally, and the dose setting member and the dose selector member 35 are moved axially relative to the snap element 33. Similar to drug delivery device 200, the dose selector member 35 is axially movable and rotated relative to the outer housing 3 of further drug delivery device 10. direction It will be fixed in place.

[0279] The portion of the dosing mechanism of most pen-type injectors, including device 10, is a piston rod 42, as shown in Figure 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 to allow the piston rod to move linearly in the proximal direction. The nut 36 and clutch member 32 are permanently splined to each other during the assembly of the dosing mechanism 30 via a spline connection 37. The spline connection 37 allows the clutch member 32 and nut 36 to rotate relative to each other during both dose setting and dose delivery. direction This ensures that it is always fixed in place. The 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 internal threads that match the corresponding external threads 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 the engagement of a connector which may be configured as a snap lock, adhesive and / or ultrasonic welding. This connection ensures that the clutch member 32 is fixed to the dose setting member 31 with respect to both rotation and axial movement 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] The proximal end of the piston rod 42 has a connector configured as a snap fit, which connects to a plunger disc or foot portion 42a. The distal end of the piston rod 42 has a stop feature portion 63 of the administration mechanism 30, illustrated as an enlarged section. This enlarged section 63 is designed to stop the nut 36 from turning around the threads 60 when the amount of drug remaining in the cartridge 8 is less than the next highest 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, preventing the nut 36 from turning further along the threads 60 as the user attempts to reach the desired predetermined fixed dose setting. According to the drug delivery device 200, a stop feature portion 243 similarly interacts with the nut 250 and therefore also prevents a dose greater than the remaining dose in the cartridge 8 from being set.

[0282] The piston rod 42 is held in a non-rotating position 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 with respect to both rotation and axial movement. Thus, the piston rod guide 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 when the piston rod guide 43 can be manufactured integrally 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 figure, the piston rod guide 43 may be configured as a reset mechanism, such as 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] A reset mechanism for the additional drug delivery device 10 may be configured as disclosed in relation to the reset mechanism 100 for the drug delivery device 200. In particular, the reset mechanism for the additional 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 with the proximal end of the rotation biasing member 90, which is shown as a torsion spring, and its function is described below. This connection of the rotation biasing member 90 to the piston rod guide 43 causes one end of the rotation biasing member 90 to rotate relative to the outer housing 3. direction It is fixed in a fixed position.

[0285] The distal end of the rotation biasing member 90 is connected to the driver 41. The driver 41 is connected to the inner surface of the administration member 330 through a spline connection on the distal outer surface of the driver 41, and rotates relative to the inner surface. direction It is fixed in place. This spline connection has at least one longitudinal ridge, such as two, located on the outer diameter of the driver 41 and engaging with corresponding grooves on the inner surface of the dosing member 330. On the proximal end of the driver 41 on its outer surface there is a thread 67 that engages with a matching thread on the distal inner surface of the piston rod guide 43.

[0286] The dosing member 330 includes, for example, two parts that are rotatable relative to each other and fixed axially by a snap-fit ​​connection. One part forms a dosing sleeve 38 connected to the driver 41 via a spline connection, and the other part forms a snap element 33. Thus, the dosing member 330 forms a single functional member.

[0287] The dosing member 330, i.e., the dosing sleeve 38, is screw-engaged to 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 threads between the driver 41 and the piston guide 43 have a significantly different pitch from the threads between the dosing member 330 and the outer housing 3. The axial sliding connection between the nut 36 and the clutch member 32 allows for compensation of the difference in thread pitch between the inner surface of the nut 36 and the outer surface of the piston rod 42, and the difference in thread pitch between the dosing member 330 and the body 3. The threads between the driver 41 and the piston guide 43 essentially have the same pitch as the threads 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 cancellation, and therefore they essentially perform the same axial movement. However, these movements are independent of each other; namely, the nut 36 is pivoted by the clutch member 32 and performs axial movement relative to the piston rod 42 due to its threads, while the driver 41 is rotated by the dosing member 330 and performs axial movement relative to the piston guide 43 due to its threads. The driver 41 also rotates during injection and therefore moves effectively proximal during injection. However, the nut 36 does not rotate during injection and therefore does not perform effective axial movement. The nut 36 moves only proximal during injection because 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 occurs because the piston rod 42 is pushed forward due to the screw-like engagement with the nut 36 by the rotating driver 41 pushing the non-rotating nut 36.

[0289] A torsion spring 90 is attached to the driver 41, and the driver 41 rotates on the dispensing member 330. directionBecause it is fixed in place, when the administration member 330 rotates in the first direction during dose setting, the torsion spring 90 winds up, and as a result, a reverse rotational force is exerted on the administration member 330 in the opposite second direction. This reverse rotational force biases the administration member 330 and causes it to rotate in the dose cancellation direction.

[0290] Generally, the further drug delivery device 10 includes a biasing member, exemplaryly configured as a torsion spring 90, which is pre-tensioned in response to an increase in the set dose. Furthermore, the biasing member is released during 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 the proximal direction. Such a biasing member may also be provided within 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, similar to how the torsion spring 90 acts between the piston guide 43 and the driver 41 of the further drug delivery device 10.

[0291] Herein, the functionality of the entire drug delivery device 10 and the administration mechanism 30 is described. The drug delivery device 10 is provided to the user as a reusable or semi-reusable device. Semi-reusable means that each time a new dispensing unit 410 having a cartridge holder 2 containing a new cartridge 8 of the drug is connected to the outer housing 3, only the administration mechanism 30 housed within the outer housing 3 is reusable. A reusable device allows the user to reattach the old or previously used cartridge holder 2 when inserting a new, complete cartridge 8 of the drug. In one configuration according to this disclosure, the device 10 has a semi-reusable design where, each time the drug in the cartridge 8 is ejected or empty, the user must disconnect a cartridge holder 2 containing an empty cartridge 8 that cannot be removed from the cartridge holder 2. Thus, the user discards both the cartridge holder 2 and the empty cartridge 8 together. The assembly of the new cartridge holder 2 and cartridge 8 is connected to the outer housing 3, provided that a keyed connecting means 510 on the outer housing 3 matches a keyed connecting means 414 provided on the distal end of the cartridge holder 2.

[0292] According to the further drug delivery device 10, the dose sleeve 38 and snap element 33 are axially and rotatably connected via a snap-fit ​​connection. direction They are fixed to each other. Thus, the dose sleeve 38 and the snap element 33 constitute a single functional element, namely the administration member 330. According to other embodiments of the further drug delivery device 10, the administration 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 that are rotatable relative to each other and fixed in the axial direction.

[0294] Similar to the drug delivery device 200, the additional drug delivery device 10 includes a clutch mechanism 237. During dose setting, the clutch mechanism 237 rotatably secures the nut 36 to the driver 41 and the dispensing member 330, while allowing rotation of the nut 36 relative to the housings 3, 43. During dose delivery, the clutch mechanism 237 rotatably secures the nut 36 to the dose selector member 35 and the housings 3, 43, while allowing relative rotation between the nut 36 on one side and the driver 41 and dispensing member 330 on the other.

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

[0296] The connector 34 is located within the annular recess of the administration member 330, and is rotatable relative to the administration member 330 and fixed in the axial direction. The connector 34 is axially movable relative to the dose selector member 35 and rotatable. direction It is fixed in place. This is achieved, exemplarily, by a radially projecting ridge 34b of the connector 34 that is received in a corresponding longitudinal groove on the inner surface of the dose selector member 35. Rotation to the dose selector member 35 direction The fixed connection also connects the connector 34 to the housing 3, 34 of the further drug delivery device 10. In contrast Rotation direction Fix it in place.

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

[0298] During dose setting, the clutch member 32 and dose setting member 31 are in their distal positions relative to the administration member 330. In this position, the dose setting member 31 is rotatably coupled to the administration member 330 via a clutch element 33a at the distal end of the snap element 33 of the administration member 330, and a first portion 238 of the clutch mechanism 237, which includes a corresponding clutch element 31a on the inner surface of the dose setting member 31, as shown in Figure 42. When the dose setting member 31 is rotated during dose setting, the administration member 330 is also rotated via the closed first portion 238 of the clutch mechanism 237 between the dose setting member 31 and the administration member 330, and is screwed out from the outer housing 3. This forces the dose selector member 35 and the dose setting member 31 to move distally as well. The rotation of the administration member 330 also forces the driver 41 to rotate in correspondence, and therefore screw it out from the piston guide 43 as well.

[0299] The nut 36 rotates relative to the clutch member 32. directionBecause it is fixed in place, during dose setting, the rotation of the dose setting member 31 also rotates the nut 36. Thus, the nut 36 moves screwwise along the piston rod 42, and also moves distally. The thread pitch of the piston rod 42 and the driver 41 is adapted so that the nut 36 and the driver 41 essentially rotate and move the same axial distance. Thus, the nominal pitch of the connection between the driver 41 and the piston guide 43 is slightly higher than the nominal thread pitch 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 dispense the set dose, the dose setting member 31, clutch member 32, and dose selector member 35 are moved to their distal positions relative to the dispensing member 330. This releases the first portion 238 of the clutch mechanism 237 between the snap element 33 of the dispensing member 330 and the dose setting member 31, and engages with the second portion 239 of the clutch mechanism 237, which is achieved between the dose setting member 31 and the connector 34 surrounding the dispensing member 330. Upon engagement with the second portion 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] The engagement of the second portion 239 of the clutch mechanism 237 rotatably locks the dose setting member 31 and the clutch member 32 to the connector 34, and also locks to the dose selector member 35 and the housings 3, 43 via the raised portion 34b of the connector 34. Thus, the nut 36 is rotatably locked to the housings 3, 43 and the piston rod 42 during dispensing. This lock 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] The disengagement of the first portion 238 of the clutch mechanism 237 allows rotational movement between the nut 36 and the driver 41 and the dosing member 330 during dose delivery.

[0303] When the dose setting member 31 is pushed further in the proximal direction, the clutch member 32 contacts the administration member 330, forcing the administration member 330 to move proximal. Due to the screw connection between the administration member 330 and the outer housing 3, the administration member 330 rotates as it moves proximal. This rotation is transmitted to the driver 41, which screws into the piston guide 43 in the proximal direction and therefore also moves axially in the proximal direction. Thus, the driver 41 contacts the nut 36 and advances it, and at this point the nut is connected to the outer housing 3 and the piston rod 42 via the clutch member 32, dose setting member 31, connector 34 and dose selector member 35. In contrast Rotation direction It is fixed in place. Therefore, both the piston rod 42 and the nut 36 rotate relative to each other. direction The nut 36 is fixed in place, and the axial advance of the nut 36 causes the corresponding axial advance of the piston rod 42, thus ejecting the set dose.

[0304] Similar to the drug delivery device 200, the additional drug delivery device 10 may also include one or more friction reduction mechanisms to reduce friction within the administration mechanism 30 during delivery of a set dose. These friction reduction mechanisms may be configured in the same manner as those disclosed in connection with the drug delivery device 200.

[0305] For example, the first friction reduction mechanism may be provided between the actuator of a further drug delivery device 10 formed by the clutch member 32 and the dispensing member 330. The clutch member 32 acts as an actuator that provides a proximal force to deliver a set dose when the user pushes the distal portion of the clutch member 32 forward.

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

[0307] In other embodiments of the further drug delivery device 10, the first friction reduction mechanism provided between the actuarial member and the dosing member 330 may also be in contact via one or more intermediate members. For example, the first friction reduction mechanism may be provided between the dose selector member 35 and the dosing member 330. When the clutch member 32 is pushed in the proximal direction, and therefore also the dose setting member 31, the proximal end of the dose selector member 35, for example, may come into contact with the dose sleeve 38, for example, with the distal end of the dose sleeve 38. In this case, the first friction reduction mechanism, such as a ball bearing 370, may be provided between the dose selector member 35 and the dose sleeve 38, for example, 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, similar to those disclosed in relation to a second friction reduction mechanism, such as a disc bearing 380, in the drug delivery device 200.

[0309] The further drug delivery device 10 includes a dose setting mechanism 232 that acts 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 Figure 41, the dosing member 330, i.e., the snap element 33, has a flexible arm 33c on its outer surface that has a radial projection 33d that forms an elastic element and engages with a dose stop portion 35a on the inner surface of the dose selector 35. The dose stop portion 35a shown in Figure 43 forms a functional feature portion 312 of the dose setting mechanism 232.

[0310] Thus, the circumferential position of each dose stop 35a defines the individual relative rotational positions between the dispensing member 330 and the housings 3 and 43 corresponding to the settable doses. A torsion spring 90 is provided between the piston guide 43 and the driver 41 to prevent the dial rotation of intermediate doses between the individual dose stop 35a. This torsion spring 90 is loaded when increasing the set dose, and when the dose setting member 31 is released while the projection 33d on the dispensing member 330 is positioned between the two dose stop 35a, the dispensing member 330 rotates back to the last set dose.

[0311] According to the further drug delivery device 10, the dispensing member 330 is restricted to performing less than one complete rotation in response to dose setting. The further drug delivery device 10 includes a stop mechanism that defines the maximum and minimum rotational positions of the dispensing member 330 during dose setting.

[0312] The stopping mechanism operates between the snap element 33 of the dosing member 330 and the dose selector member 35. The stopping mechanism includes a further projection 33f located on the outer surface of the dosing member 330 and projecting radially toward the dose selector member 35. The dose selector member 35 is located on the inner surface of the dose selector member 33 and includes a maximum stopping feature 35b, which is configured as a stepped side surface located on the inner surface. Furthermore, the dose selector member 35 includes a zero stopping feature 35c, also located on the inner surface of the dose selector member 33. The zero stopping feature 35c is exemplary configured as a stepped side surface facing the side surface forming the maximum stopping feature 35b. According to other embodiments of the dose selector member 33, the zero stopping feature 35c and the maximum stopping feature 35b may also be provided on separate projections or steps on the inner surface of the dose selector member 33.

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

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

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

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

[0317] In one embodiment, several variations of the further drug delivery device 10 include an outer housing 3, a cap 1, a dose sleeve 38, and a dose selector member 35 as distinguishing members. The outer housing 3 differs in shape due to differences in the connecting means 510 and also 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 dose stop sections 35a, thereby enabling different dial rotation resolutions or configurable doses. Alternatively or additionally, the dose selector member 35 may also differ in the position of the maximum stop feature section 35c. The dose sleeve 38 is mechanically identical among the individual variations but differs in appearance due to different positions and / or numbering of their optical markers. The cap 1 is identical in shape but differs in appearance, such as color and / or labeling. According to other embodiments, the cap 1 may also be configured as a reciprocal member.

[0318] In this case, the intercomponents of the modified form of the further drug delivery device 10 may be all other elements of the administration mechanism 30.

[0319] According to both types of drug delivery devices 10, 200, the mechanical advantages of the administration mechanism 230 during dose distribution may differ among the devices in individual sets. For example, a set may include one device that has a higher mechanical advantage than another device in each set. Among these devices, the drivers 41, 350, and the parts of the housing 210 that are screw-connected to the drivers 41, 350, such as the inner housing 180 and the piston guide 43, may be mechanically distinct members due to the different pitches of their threads 67, 186, and 353. Additionally or alternatively, the administration member 330, particularly the dose sleeve 38, and the parts of the housing 210 that are screw-connected to the administration member 330, such as the inner housing 180 and the housing 3, may be mechanically distinct members due to the different pitches of their threads 39, 185, and 335. All sets of drug delivery devices 10, 200 described herein may include drug delivery devices 10, 200 that have different mechanical advantages of their administration mechanism 230 during dose distribution.

[0320] Figures 44 and 45 show alternative embodiments of the reset element 110 of the drug delivery device 200. Unless otherwise noted or evident from the figures, the reset element 110 in the alternative embodiments is 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. These guide structures are arranged on the circumferential side walls of the cartridge cavity 115. Thus, the guide structures 116 are spaced equally apart from one another. According to the embodiments shown in Figures 44 and 45, the reset element 110 includes, exemplary, eight guide structures 116. According to other embodiments, the reset element 110 may include more or fewer guide structures 116.

[0322] The guide structure 116 is configured to center the distal end of the cartridge 8 with respect to the longitudinal axis 207 when the distribution unit 410 is attached to the drug delivery device 200. The guide structure 116 touches the cartridge 8 in the radial direction as it is inserted into the cartridge holder 412. Therefore, these guide structures define only the lateral position of the cartridge 8 with respect to the longitudinal axis 207, and do not define the axial position of the distal end of the cartridge 8. Furthermore, the axial position of the distal end of the cartridge 8 does not define the axial position of the reset element 110.

[0323] The guide structure 116 is configured to prevent it from being pushed forward by the cartridge 8 during the attachment of the distribution unit 410 to the drug delivery device 200. The guide structure 116 includes a proximal-facing inclined front surface 116a. The inclined front surface 116a centers the cartridge 8 but prevents the reset element 110 from receiving an axial force through the cartridge 8 that would displace the reset element 110 axially. The guide structure 116 also includes a distal-facing inclined rear surface 116b.

[0324] Both the front surface 116a and the rear surface 116b may have angles with respect to the longitudinal axis 207, up to a maximum of 45°, for example, up to 30°, 20°, or 10°. For example, the front surface 116a may have angles with respect to the longitudinal axis 207 that are 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 equal to, for example, 20°. The rear surface 116b may have angles with respect to the longitudinal axis 207 that are 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 equal to, for example, 1°.

[0325] Figure 46 shows an alternative embodiment of the coupling portion 130 of the drug delivery device 200. Unless otherwise noted or evident from the figure, the coupling portion 130 in the alternative embodiment is 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 joint portion 130 comprises four projections 138. The projections 138 are circumferentially distributed around the longitudinal axis 207 and are equally spaced apart from each other in the circumferential direction.

[0327] Furthermore, an alternative embodiment of the joint portion 130 includes recesses 139a in addition to the slots 139. In Figure 46, the joint portion 130 is shown exemplary having two recesses 139a. The recesses 139a are located at the distal end of the joint portion 130. Each recess 139a is centered with one of the first locking structures 137, dividing each first locking structure 137 into two parts. As can be seen further from Figure 46, the slots 139 and recesses 139a are alternately distributed circumferentially and spaced equally apart from one another.

[0328] Figure 47 shows alternative embodiments of the reset element 110 and alternative embodiments of the coupling portion 130 mounted on an alternative embodiment of the inner housing 180. Unless otherwise noted or evident 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] An alternative embodiment of the inner housing 180 comprises one of the tappets 184 for each of the slots 139 and recesses 139a. Thus, in general, the inner housing 180 comprises four tappets 184. The tappets 184 are located at the proximal end of the inner housing 180. Furthermore, the tappets are spaced equally apart from each other in the circumferential direction around 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 otherwise noted or evident from the figures, alternative embodiments of the inner housing 180 and / or alternative embodiments of the dose selector member 310 are configured as described above in relation to other embodiments of the inner housing 180 and dose selector member 310 according to this disclosure.

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

[0332] When the maximum dose is set, the stopping surface 338 of the maximum dose stopping section 337 abuts against the limiting surface 192 of the maximum stopping feature section 190. Furthermore, the radial projection 198a is received within the recess 193. According to the embodiment of the drug delivery device 200 shown in Figures 48 to 51, the inner housing 180 comprises two maximum stopping feature sections 190 positioned opposite each other with respect to the longitudinal axis 207. Instead of two further maximum stopping feature sections 190, the inner housing 180 comprises two longitudinal slots 198 having recesses 193 at their distal ends. The longitudinal slots 198 having recesses 193 are also positioned 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 recess 193 are provided between the dose selector member 310 and the inner housing 180 and may serve as an additional maximum dose stop mechanism that restricts the axial movement of the administration member 330 and the dose selector member 310 in response to the setting of the maximum settable dose. Alternatively or additionally, the radial projection 319a and recess 193 may provide locking means to prevent the dose selector member 310 from detaching from the housing 210 after the assembly of the drug delivery device 200. For example, the radial projection 319a and recess 193 may be configured not to touch each other due to engagement between the stopping surface 338 and the limiting surface 192, and only to touch in response to further forced distal movement of the dose selector member 310. Alternatively, the radial projection 319a and recess 193 may be configured to touch essentially at the same time that the stopping surface 338 touches the limiting surface 192.

[0334] As can be seen from Figures 49 and 50, the inner housing 180, configured to accommodate an alternative embodiment of the dose selector member 310 having a radial projection 319a, may also have four tappets 183 and may be configured for use in a drug delivery device 200 featuring an alternative embodiment of the 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 the coupling portion 130 described in relation to Figures 27 to 33.

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

[0336] Since the description is based on the first drug delivery device 220, the second drug delivery device 222, and the third drug delivery device 225, the clutch mechanism 234 of the individual drug delivery devices 220, 222, 225 of the individual sets may define a different number of rotatable coupling positions in which the first part 235 of the clutch mechanism 234 can close to rotatably couple the nut 250 and / or clutch member 270 to the administration member 330. These rotatable coupling positions are defined by the circumferential positions of the clutch elements 273, 336.

[0337] The angular interval of the rotational coupling positions corresponds to the angular interval between dose positions that can be set by rotating the dose setting member 290. According to the type of drug delivery device 200 described in relation to Figures 1 to 37 and Figures 44 to 51, the angular interval between rotational coupling positions is equal to the angular interval between dose positions. Generally, these positions may correspond such that the angular interval between dose positions is an integer multiple of the angular interval between coupling positions. For example, depending on the circumferential position of the dose stop portion 35a on the inner surface of the dose selector member 35 of the drug delivery device 10, the angular interval between dose positions defined by the dose stop portion 35a may be an integer multiple of the rotational 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 rotational coupling position. Therefore, in principle, a single clutch element 336 on the administration member 330 is sufficient to define the rotational coupling positions. According to an alternative embodiment of the clutch member 270, the number of clutch elements 273 may also differ from the number of rotational coupling positions. For example, the number of clutch elements 273 may be less than the number of rotational coupling positions per rotation of the dose setting member 290. Thus, the number of clutch elements 273 may be less by at least one, at least two, or more clutch elements 273, such as one or two.

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

[0340] Figure 52 shows an alternative embodiment of the clutch member 270 of the drug delivery device 200. Unless otherwise noted or evident from the figures, the alternative embodiment of the clutch member 270 is configured as disclosed in relation to the clutch member 270 described above.

[0341] In an alternative embodiment of the clutch member 270, the number of clutch elements 273 is two less than the number of rotational coupling positions. The clutch elements 273 are located adjacent to each other within two groups, each group containing the same number of clutch elements 273, i.e., eight clutch elements 273, and the clutch elements 273 in each group are spaced equally apart from one another. A ninth clutch element 273 is missing in the gap between the two groups. The two groups of clutch elements 273 are spaced circumferentially apart from each other by twice the distance between the clutch elements 273 in each group.

[0342] The drug delivery devices 10, 200, 220, 222, and 225 according to this disclosure may be equipped with counterweights. The counterweights may be located offset from the longitudinal axis 207 of the devices 10, 200, 220, 222, and 225, so that the center of gravity of the devices 10, 200, 220, 222, and 225 is shifted from the longitudinal axis 207 toward the outer shell of the devices 10, 200, 220, 222, and 225. This prevents the devices from rolling when the devices 10, 200, 220, 222, and 225 are placed on a flat surface.

[0343] Figure 53 shows a perspective view of a drug delivery device 200 without an outer housing 211, equipped with such a counterweight 160, and Figure 54 shows a radial cross-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. Thus, the counterweight is positioned between the inner housing 180 and the outer housing 211, and between the administration mechanism 230 and the outer housing 211.

[0344] The counterweight 160 is positioned on the outer surface 199 of the inner housing 180. The counterweight has a curved bottom surface 161 facing the longitudinal axis 207 and a curved top surface 162 facing outward from the longitudinal axis 207. The bottom surface 161 forms a segment of a cylindrical shell having a pivot axis coincident with the longitudinal axis 207. Similarly, the top surface 162 forms a segment of a cylindrical shell having a pivot axis coincident with the longitudinal axis 207. The bottom surface 161 and the top surface 162 are oriented parallel to each other.

[0345] The counterweight 160 is formed on the outer surface 199 of the inner housing 180, and in particular, within the seat 170 depicted in Figure 55. The seat 170 supports the counterweight 160 and includes a support surface 175 on which the bottom surface 161 of the counterweight 160 leans. The support surface 175 is formed by the outer surface 199 of the inner housing 180. Furthermore, the seat 170 includes at least one, i.e., two, first longitudinal stop elements 171 that divide the seat 170 toward the proximal end 205, and second longitudinal stop elements 173 that divide the seat 170 toward the distal end 206. To prevent rotation of the counterweight 160 in the circumferential direction, the seat 170 includes two circumferential stop elements 172 that restrict the seat 170 in the circumferential direction.

[0346] The first longitudinal stop element 171 is configured as a projection located on the outer surface 199 of the inner housing 180. The first longitudinal stop elements 171 are spaced apart from each other in the circumferential direction and are located in the same axial position along the longitudinal axis 207. The first longitudinal stop element 171 has an elongated shape oriented perpendicular to the longitudinal axis 207.

[0347] The second longitudinal stop element 173 is configured as a projection that forms a step within 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 oriented perpendicular to the longitudinal axis 207.

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

[0349] As can be seen in Figure 54, the seat portion is covered by the outer housing 211. The counterweight 160 is configured such 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 portion 170 forms a cavity into which the counterweight 160 is inserted. Thus, the counterweight 160 is held in place only by the stop elements 171, 172, 173, the support surface 175, and the inner surface of the outer housing 211.

[0350] As can be further seen from Figure 54, the counterweight 160 causes the center of gravity 208 of the drug delivery device 200 to be positioned outward from the longitudinal axis 207 of the device 200 toward 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 smaller than the distance between the center of gravity 208 and the longitudinal axis 207.

[0351] The counterweight 160, as well as the windows in the housing 210, which are exemplary formed by the window 211a in the outer housing 211 and the window 180a in the inner housing 180, are located at different angular positions with respect to the longitudinal axis 207. In the exemplary embodiment of Figure 54, the counterweight 160 and the windows in the housing 210 are located at 180° different angular positions and thus correspond to opposing 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 come into contact with a flat surface when the drug delivery device 200 rolls with the cap 209 not on the surface. According to the drug delivery device 200, the contact surface has a cylindrical outer surface that lacks any protrusions that would impede the rolling of the housing 210 when it is positioned on a flat surface. Due to the counterweight 160, the drug delivery device 200 takes a stable position and rotates on the flat surface until its center of gravity 280 is located between the surface and the longitudinal axis 207.

[0353] In the stable position, the window within the housing 210 is located on the upper side of the drug delivery device 200, facing outward from the surface on which the drug delivery device 200 is positioned. 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, for example, the lateral side.

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

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

[0356] The counterweight 160 has a first projection 163 on one longitudinal end face and a second projection 165 on the opposite longitudinal end face. When inserted into the seat 170, one of the projections 163, 165 as shown in Figure 56, for example, the first projection 163, is positioned as a proximal projection between the first longitudinal stop elements 171. Two front surfaces 164 of the counterweight 160, extending radially from the proximal projection and receding along the longitudinal axis 207 relative to the proximal projection, are configured to abut against the first longitudinal stop elements 171. The other of the projections 163, 165 shown in Figure 56, for example, the second projection 165, is then configured to abut against the second longitudinal stop element 173 as a distal projection. The width of the counterweight 160 perpendicular to the longitudinal axis 207 is adapted to allow the counterweight 162 to be positioned between the circumferential stopping elements 172.

[0357] According to other embodiments, the distance between the counterweight 160 and the center of gravity 208 may also be smaller than the distance between the center of gravity 208 and the longitudinal axis 207, as can be seen from Figure 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. By positioning the center of gravity 208 closer to the longitudinal axis 207 than the counterweight 160, it becomes possible to use a relatively small counterweight 160 while still shifting the center of gravity outward from the longitudinal axis 207.

[0358] The cross-sectional views in Figures 54 and 57 only schematically show the radial position of the center of gravity 208. According to the drug delivery device 200, the longitudinal position of the center of gravity 208 does not have to 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 located, for example, distal to the longitudinal center of the window 211a within the outer housing 211 along the longitudinal axis 207, or proximal to the longitudinal center of the window 211a within the outer housing 211 along the longitudinal axis 207.

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

[0360] 1. A drug delivery device (10, 200, 220, 222, 225) for dispensing a user-configurable dose, Housing (3, 43, 210, 221, 223, 226) and A dose selector member (35, 310) is rotatably fixed to the housing (3, 43, 210, 221, 223, 226) at least during dose setting, and is axially movable relative to the housing (3, 43, 210, 221, 223, 226), The administration member (330) and Dose-regulating mechanism (232) and It has, The dispensing member (330) is configured to rotate relative to the dose selector members (35, 310) in order to change the set dose. A drug delivery device (10, 200, 220, 222, 225) is configured such that a dose-determining mechanism (232) defines discrete relative rotational positions of a dispensing member (330) and a dose selector member (35, 310) corresponding to a configurable dose of the device.

[0361] 2. The drug delivery device (10, 200, 220, 222, 225) according to Embodiment 1, wherein the administration member (330) is rotatable 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) according to Embodiment 1 or 2, wherein the axial distance (x) that the administration member (330) advances from the zero dose position of the administration 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 administration 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 dispensing member (330), together with the dose selector members (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 screw-coupled to the housing (3, 43, 210, 221, 223, 226).

[0366] 7. The 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 the interaction between two members of the drug delivery device (10, 200, 220, 222, 225) that rotate relative to each other in response to a change in the set dose during dose setting.

[0367] 8. A drug delivery device according to Embodiment 7 (10, 200, 220, 222, 225), wherein the two members interact by an elastic element (33c, 33d, 292) of one of the two members resting on at least one rigid element (35a, 312), such as a dose-stopping portion (35a), of the other of the two members.

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

[0369] 10. The drug delivery device according to 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. The device is equipped with a dose setting member (31, 290) that can be operated by the user to set the dose. A dose-determining mechanism (232) acts between a dose-setting member (31, 290) and a dose-selector member (35, 310) in a drug delivery device (10, 200, 220, 222, 225) according to at least one of embodiments 1 to 10.

[0371] 12. The drug delivery device (10, 200, 220, 222, 225) according to Embodiment 11, wherein the dose setting members (31, 290) are configured to be axially movable together with the dose selector members (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 members (31, 290) are rotatably locked relative to the dose selector members (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 members (31, 290) are axially movable relative to the dose selector members (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 setting mechanism (232) is realized by direct engagement of a dose setting member (31, 290) or a portion permanently fixed to the dose setting member (31, 290) together with a dose selector member (35, 310), or a portion permanently fixed to the dose selector member (35, 310).

[0375] 16. The dose-regulating mechanism (232) comprises a functional feature section (35a, 312), for example, at least one elastic element (33c, 33d, 292) that engages with the dose-removal section, A drug delivery device (10, 200, 220, 222, 225) according to at least one of embodiments 1 to 15, wherein the circumferential positions of the functional feature portions (35a, 312) around the longitudinal axis (207) of the drug delivery device (10, 200, 220, 222, 225) define the rotational position of the administration member (330) corresponding to a settable dose.

[0376] 17. Functional feature parts (35a, 312) are located directly adjacent to each other in the drug delivery device (10, 200, 220, 222, 225) according to Embodiment 16.

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

[0378] 19. The clutch mechanism is a drug delivery device (10, 200, 220, 222, 225) according to Embodiment 18 and at least one of Embodiments 16 and 17, comprising functional feature parts (35a, 312).

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

[0380] 21. The drug delivery device (10, 200, 220, 222, 225) according to Embodiment 20, wherein the clutch element (294) is positioned collinear with the elastic elements (33c, 33d, 292) in the 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 elements (294) and / or functional feature portions (35a, 312) and / or elastic elements (33c, 33d, 292) have angled flat sides for engaging with each other.

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

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

[0384] 25. A drug delivery device (10, 200, 220, 222, 225) according to at least one of embodiments 1 to 24, wherein the rotating portion of the drug delivery device (10, 200, 220, 222, 225) is not accessible to the user of the drug delivery device (10, 200, 220, 222, 225) during dose delivery.

[0385] This disclosure also generally covers the connecting means 414, 424, 434, 444, 510, 511, 520, 530 of the drug delivery devices 10, 200, 220, 222, 225 and / or distribution units 410, 420, 430, 440. The structure and details of these connecting means 414, 424, 434, 444, 510, 511, 520, 530 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 stop units 35a, 35b, 35c, the reset mechanism 100, or the counterweight 160. For example, this disclosure covers 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 equipped with a first keyed connection means (510, 511, 520, 530), A second drug delivery device (10, 200, 220, 222, 225) having a proximal end equipped with a second keyed connection means (510, 511, 520, 530) and Equipped with, The first keyed connecting means (510, 511, 520, 530) of the first drug delivery device (10, 200, 220, 222, 225) are configured to engage with the first keyed connecting means (414, 424, 434, 444) of the first distribution unit (410, 420, 430, 440) and to form a connection with the first keyed connecting means (414, 424, 434, 444), and the second drug delivery device (10, The second keyed connecting means (510, 511, 520, 530) of units 200, 220, 222, 225) are configured to engage with the second keyed connecting means (414, 424, 434, 444) of the second distribution unit (410, 420, 430, 440) which is different from the first distribution unit (410, 420, 430, 440), and to form a connection with the second keyed connecting means (414, 424, 434, 444). A set in which the first keyed connecting means (510, 511, 520, 530) of the first drug delivery device (10, 200, 220, 222, 225) are configured not to form a connection with the second keyed connecting means (414, 424, 434, 444) of the second distribution 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) are configured not to form a connection with the first keyed connecting means (414, 424, 434, 444) of the first distribution unit (410, 420, 430, 440).

[0387] 2. The set according to Embodiment 1, wherein each of the keyed connecting means (510, 511, 520, 530) of the drug delivery device (10, 200, 220, 222, 225) includes, for example, a threaded configuration.

[0388] 3. The set of keyed connecting means (510, 511, 520, 530) of the drug delivery devices (10, 200, 220, 222, 225) each includes a male screw thread configuration, as described in Embodiment 2.

[0389] 4. The set according to one of Embodiments 2 and 3, wherein the thread configurations of the keyed connecting means (510, 511, 520, 530) of the drug delivery devices (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 configurations of the keyed connecting means (510, 511, 520, 530) of the drug delivery devices (10, 200, 220, 222, 225) each have different outer diameters (D1, D2, D3).

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

[0392] 7. The thread configuration of the keyed connecting means (510, 511, 520, 530) of the drug delivery device (10, 200, 220, 222, 225) is a set according to any one of Embodiments 2 to 6, wherein at least one thread dimension differs, such as the 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. A set according to any one of Embodiments 2 to 7, wherein the thread configurations of the keyed connecting means (510, 511, 520, 530) of the drug delivery devices (10, 200, 220, 222, 225) each have the same pitch (P1, P2, P3).

[0394] 9. A set according to any one of Embodiments 2 to 8, wherein the thread configurations of the keyed connecting means (510, 511, 520, 530) of the drug delivery devices (10, 200, 220, 222, 225) each have different thread widths (w1, w2, w3).

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

[0396] 11. A set according to any one of Embodiments 2 to 10, wherein the thread configurations of the keyed connecting means (510, 511, 520, 530) of the drug delivery devices (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 connection means (511) of the first drug delivery device (220) is greater than the thread height (h2, h3) of the keyed connection means (520, 530) of the second drug delivery device (222, 225), for example, twice or three times greater.

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

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

[0400] 15. A set of two or more distribution units (410, 420, 430, 440), A first distribution unit (410, 420, 430, 440) having a distal end equipped with a first keyed connection means (414, 424, 434, 444), A second distribution unit (410, 420, 430, 440) having a distal end equipped with a second keyed connection means (414, 424, 434, 444) and Equipped with, The first keyed connecting means (414, 424, 434, 444) of the first distribution unit (410, 420, 430, 440) are 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 to form a connection with the first keyed connecting means (510, 511, 520, 530), and the second distribution unit (410, 420, The second keyed connecting means (414, 424, 434, 444) of 430, 440) are configured to engage with the second keyed connecting means (510, 511, 520, 530) of the second drug delivery device (10, 200, 220, 222, 225), which is different from the first drug delivery device (10, 200, 220, 222, 225), and to form a connection with the second keyed connecting means (510, 511, 520, 530). A set in which the first keyed connecting means (414, 424, 434, 444) of the first distribution unit (410, 420, 430, 440) are 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 distribution unit (410, 420, 430, 440) are 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).

[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, such as insulin or HGH.

[0402] 17. The fluids in the drug compartments (81) of the distribution units (410, 420, 430, 440) are different from each other, at least in terms of drug concentration, as in the set described in Embodiment 16.

[0403] 18. A set according to any one of embodiments 15 to 17, wherein each of the dispensing units (410, 420, 430, 440) has an open distal end configured to allow axial movement of a piston rod (42, 240) contained within a corresponding drug delivery device (10, 200, 220, 222, 225), and as a result, when mounted on the corresponding drug delivery device (10, 200, 220, 222, 225), the piston rod (42, 240) can move beyond its distal end into the dispensing unit (410, 420, 430, 440).

[0404] 19. The keyed connecting means (414, 424, 434, 444) of the distribution units (410, 420, 430, 440) each include a threaded form, for example, a set according to any one of embodiments 15 to 18 consisting of a threaded form.

[0405] 20. The keyed connecting means (414, 424, 434, 444) of the distribution units (410, 420, 430, 440) each include a female screw thread configuration, as described in Embodiment 19.

[0406] 21. The set according to one of embodiments 19 and 20, wherein the thread configurations 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. A set according to any one of embodiments 19 to 21, wherein the thread configurations of the keyed connecting means (414, 424, 434, 444) of the distribution units (410, 420, 430, 440) each have different outer diameters (D1, D2, D3).

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

[0409] 24. A set according to any one of embodiments 19 to 23, wherein the thread configurations 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. A set according to any one of embodiments 19 to 24, wherein the thread configurations of the keyed connecting means (414, 424, 434, 444) of the distribution units (410, 420, 430, 440) each have different thread widths (w1, w2, w3).

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

[0412] 27. A set according to any one of embodiments 19 to 26, wherein the thread configurations of the keyed connecting means (414, 424, 434, 444) of the distribution 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 connector (424) of the first distribution unit (420) is greater than the thread height (h2, h3) of the keyed connector (434, 444) of the second distribution unit (430, 440), for example, twice or three times greater.

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

[0415] 30. At least the keyed connecting means (414, 424, 434, 444) of the distribution units (410, 420, 430, 440) are formed by injection molding, as per any one of embodiments 15 to 29.

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

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

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

[0419] 1. 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 cartridge holders (2, 412, 422, 432, 432) are configured to receive cartridges (8) having drug compartments (81) filled with a drug, The cartridge holders (2, 412, 422, 432, 432) are equipped with locking elements (404) configured to permanently connect the cartridges to the cartridge holders (2, 412, 422, 432, 432) in a way that prevents them from being released while the distribution units (410, 420, 430, 440) are in use.

[0420] 2. The cartridge holder (2, 412, 422, 432, 432) according to Embodiment 1, further comprising 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. The biasing element (406) is configured separately from the locking element (404) in the cartridge holder (2, 412, 422, 432, 432) according to Embodiment 2.

[0422] 4. The cartridge holder (2, 412, 422, 432, 432) according to Embodiment 3, wherein the biasing element (406) and the locking element (404) are located on opposing sides of the cartridge holder (2, 412, 422, 432, 432).

[0423] 5. The biasing element (406) and the locking element (404) are located at the same longitudinal position on the cartridge holder (2, 412, 422, 432, 432) as described in at least one of embodiments 3 and 4 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 on the same surface (83) of the cartridge holder (8).

[0425] 7. The biasing element (406) is located within the proximal portion of the cartridge holder (2, 412, 422, 432, 432) such as the proximal half, proximal third, or proximal quarter of the cartridge holder (2, 412, 422, 432, 432) as described in at least one of embodiments 2 to 6.

[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) in response to 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 the distal surface (83) of the cartridge (8) facing outward from the needle end of the cartridge holder (2, 412, 422, 432, 432) after insertion.

[0429] 11. A 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 a biasing element (406) is configured to bias the cartridge (8) against a stopper (408) configured to prevent proximal movement of the cartridge (8).

[0432] 14. A cartridge holder according to at least one of embodiments 2 to 13, wherein the biasing element (406) is configured to clamp the cartridge (8) between the stopper (408) and the biasing element (406), so that both the stopper (408) and the biasing element (406) lean against the cartridge (8) simultaneously.

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

[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) outward from the contact surface (405) of the locking element (404).

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

[0436] 18. The biasing element (406) is configured as a notched portion of the cartridge holder (2, 412, 422, 432, 432) as described in Embodiment 17 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 deflect toward the longitudinal axis (207) of the cartridge holder (2, 412, 422, 432, 432) when the cartridge (8) engages with the locking element (404) in response to an attempt to remove the cartridge (8) from the cartridge holder (412).

[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) comprises a contact surface (405) configured to engage with the cartridge (8) to prevent the cartridge (8) from being removed from the cartridge holder (2, 412, 422, 432, 432).

[0439] 21. 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), as described in Embodiment 20.

[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. The contact surface (405) is located outward from the cartridge (8) after the cartridge (8) has been fully inserted into the cartridge holder (2, 412, 422, 432, 432) as described in at least one of embodiments 19 to 22 of 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 the distal surface (83) of the cartridge (8) facing outward from the needle end of the cartridge holder (2, 412, 422, 432, 432) after insertion.

[0443] 25. A 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 locking element (404) is designed as a snap-fit ​​connection, for example, as a snap hook, in the cartridge holder (2, 412, 422, 432, 432) according to at least one of embodiments 1 to 25.

[0445] 27. The locking element (404) is configured as an integral part of the cartridge holder (2, 412, 422, 432, 432) according to at least one of embodiments 1 to 26.

[0446] 28. The cartridge holder (2, 412, 422, 432, 432) according to Embodiment 27, wherein the locking element (404) is configured as a notched portion of the cartridge holder (2, 412, 422, 432, 432).

[0447] 29. The locking element (404) is located within the proximal portion of the cartridge holder (2, 412, 422, 432, 432) such as the proximal half, proximal third, or proximal quarter of the cartridge holder (2, 412, 422, 432, 432) as described in at least one of embodiments 1 to 28.

[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, comprising connecting means (414, 424, 434, 444) configured to connect to corresponding connecting means (510, 511, 520, 530) of a drug delivery device (10, 200, 220, 222, 225) for detachably connecting the cartridge holder (2, 412, 422, 432, 432) to a drug delivery device (10, 200, 220, 222, 225).

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

[0451] 33. A set of cartridge holders (2, 412, 422, 432, 432) and a cartridge (8) containing a drug, according to at least one of embodiments 1 to 32, The cartridge (8) is inserted into the cartridge holder (2, 412, 422, 432, 432) and held in a non-removable manner within the cartridge holder (2, 412, 422, 432, 432), forming a set.

[0452] The drug delivery devices described herein are further characterized by the embodiments listed below.

[0453] 1. Drug delivery devices (10, 200, 220, 222, 225), Housings (3, 43, 210, 221, 223, 226) having a longitudinal axis (207), To set the dose delivered by the drug delivery device (10, 200, 220, 222, 225), a dose setting member (31, 290) is provided, which is user-operable and rotatable about a longitudinal axis (207), To deliver a set dose, a piston rod (42, 240) is configured to advance axially, for example, proximal outward from the housing (3, 43, 210, 221, 223, 226), It has a dispensing member (330) for defining the axial advance of the piston rod (42, 240) when delivering a set dose, The dispensing member (330) is axially movable along the longitudinal axis (207) during dose setting, and is capable of rotational movement about the longitudinal axis (207). The administration member (330) is rotatably fixed to the dose setting members (31, 290) during dose setting. The administration member (330) is equipped with a maximum dose stop unit (337). The maximum dose stop unit (337) is configured to engage with the maximum stop feature unit (190) to restrict the movement of the administration member (330) relative to the housing (3, 43, 210, 221, 223, 226) when the maximum dose is set. The maximum stopping feature section (190) is a drug delivery device (10, 200, 220, 222, 225) located in the housing (3, 43, 210, 221, 223, 226).

[0454] 2. The drug delivery device (10, 200, 220, 222, 225) according to Embodiment 1, wherein the administration member (330) is rotatable relative to the dose setting members (31, 290) during dose delivery.

[0455] 3. The dispensing member (330) is configured to perform more than one full rotation relative to the housing (3, 43, 210, 221, 223, 226) during dose setting, for example, at least two full rotations. For example, the drug delivery device (10, 200, 220, 222, 225) according to Embodiment 1 or 2, wherein the administration member (330) is configured to perform two full 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 administration member (330) is screw-connected to the housing (3, 43, 210, 221, 223, 226) via, for example, 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).

[0457] 5. A drug delivery device (10, 200, 220, 222, 225) according to one of embodiments 1 to 4, wherein the dispensing 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 section (337) includes a stop surface (338) configured to abut axially against the maximum stop feature section (190) of the housing (3, 43, 210, 221, 223, 226) when setting the maximum dose.

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

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

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

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

[0463] 11. The maximum stopping feature portion (190) of the housing (3, 43, 210, 221, 223, 226) has a limiting surface (192) oriented perpendicular to the longitudinal axis (207), A drug delivery device according to one of embodiments 1 to 10 (10, 200, 220, 222, 225), wherein a maximum dose stop unit (337) engages with a limiting surface (192) when setting the maximum dose.

[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 ​​onto the maximum dose stop (337) of the administration member (330) during assembly of the drug delivery device (10, 200, 220, 222, 225).

[0465] 13. A drug delivery device (10, 200, 220, 222, 225) according to Embodiment 12, wherein the flexible element (191) leans against a backing element such as an outer housing (211) surrounding an inner housing (180) having the flexible element (191) to prevent the maximum stop feature (190) from being disengaged from the maximum dose stop feature (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 administration member (330) is configured as a dose indicator member that provides the user with a visual indicator of a set dose via corresponding optical markers (40, 331) on the outer surface of the administration 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 members (31, 290) are configured to move axially with the administration member (330) relative to the housing (3, 43, 210, 221, 223, 226).

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

[0469] 17. The zero-dose stop unit (340) engages with the zero-stop feature unit (196) in a contact plane that is angled with respect to a radial plane perpendicular to the longitudinal axis (207), For example, the drug delivery device according to Embodiment 16 (10, 200, 220, 222, 225) has a contact plane 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 section (340) of the administration member (330) includes a stop surface configured to abut against a corresponding stop surface of the housing (3, 43, 210, 221, 223, 226).

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

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

[0473] 21. A drug delivery device (10, 200, 220, 222, 225) according to Embodiment 20, comprising a dose thread (185) that engages with a dispensing member (330) in a screw-like manner.

[0474] 22. The structural element comprises a drive thread (186) that engages screw-type with the drivers (41, 350) of the drug delivery device (10, 200, 220, 222, 225), A drug delivery device (10, 200, 220, 222, 225) according to one of embodiments 20 and 21, wherein a driver (41, 350) is coupled to a piston rod (42, 240) during dose delivery to advance the piston rod (42, 240) axially when the driver (41, 350) moves axially.

[0475] 23. The drug delivery device (10, 200, 220, 222, 225) is equipped with a dose setting mechanism (232) for defining the rotational dose position of the dose setting member (31, 290) relative to the housing (3, 43, 210, 221, 223, 226), The dose setting members (31, 290) are connected to the housing (3, 43, 210, 221, 223, 226) via the dose selector members (35, 310). The dose selector members (35, 310) are rotatably fixed to the housing (3, 43, 210, 221, 223, 226) and are movable in the axial direction. The dose-determining mechanism (232) operates between a dose selector member (35, 310) and a dose setting member (31, 290) in the drug delivery device (10, 200, 220, 222, 225) according to one of embodiments 1 to 22.

[0476] 24. A drug delivery device (10, 200, 220, 222, 225) according to Embodiment 23, wherein the dose selector members (35, 310) are fixed axially to the administration member (330).

[0477] 25. The dose selector members (35, 310) are connected to the housings (3, 43, 210, 221, 223, 226) via connections (187, 188, 315, 316) that enable the dose selector members (35, 310) to be mounted on the housings (3, 43, 210, 221, 223, 226) only in a rotational direction that ensures the dose setting members (31, 290) are set to the dose position when engaged with the maximum stop feature section (190) of the maximum dose stop section (337). For example, the connections (187, 188, 315, 316) in the drug delivery device (10, 200, 220, 222, 225) described in one of embodiments 23 and 24 allow only a single rotational direction.

[0478] 26. The connections (187, 188, 315, 316) include spline connections that allow axial movement of the dose selector members (35, 310) relative to the housings (3, 43, 210, 221, 223, 226) and prevent rotational movement. The spline connection includes a set of coding splines, each having different dimensions, for example, width and / or height, as described in Embodiment 25 of the drug delivery device (10, 200, 220, 222, 225).

[0479] 27. The drug delivery device (10, 200, 220, 222, 225) according to 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 administration member (330) is coupled to the piston rod (42, 240) via a forward mechanism that converts the axial movement of the administration member (330) into axial forward movement of the piston rod (42, 240) during dose delivery, and as a result, the axial movement of the administration member (330) during dose delivery causes the piston rod (42, 240) to advance proximal in the axial direction.

[0481] 29. The drug delivery device (10, 200, 220, 222, 225) according to Embodiment 28, wherein the forward movement mechanism is configured as a gearing mechanism that reduces the axial movement of the administration member (330) to a smaller axial forward movement of the piston rods (42, 240).

[0482] 30. The piston rods (42, 240) are rotatably fixed to the housing (3, 43, 210, 221, 223, 226), The forward mechanism includes a connecting nut (36, 250) between the piston rod (42, 240) and the dosing member (330), The nuts (36, 250) are threaded to the piston rods (42, 240). During dose setting, the nuts (36, 250) are rotatably fixed to the dispensing member (330) and rotatably fixed to the housing (3, 43, 210, 221, 223, 226). During dose delivery, the nuts (36, 250) are rotatable relative to the dispensing member (330) and rotatably fixed relative to the housing (3, 43, 210, 221, 223, 226), in the drug delivery device (10, 200, 220, 222, 225) according to one of embodiments 28 and 29.

[0483] 31. The forward mechanism includes a driver (41, 350) coupled between a nut (36, 250) and a dosing member (330), The drivers (41, 350) are rotatably fixed to the dispensing member (330) and are axially movable relative to the dispensing member (330) during both dose setting and dose delivery. The drivers (41, 350) are screw-type connected to the housings (3, 43, 210, 221, 223, 226). A drug delivery device (10, 200, 220, 222, 225) according to Embodiment 30, wherein the driver (41, 350) is configured to engage with the nut (36, 250) during dose delivery to advance the nut (36, 250) and piston rod (42, 240) axially when rotated by the dispensing member (330).

[0484] 32. Drug delivery devices (10, 200, 220, 222, 225), Housings (3, 43, 210, 221, 223, 226) having a longitudinal axis (207), To set the dose delivered by the drug delivery device (10, 200, 220, 222, 225), a dose setting member (31, 290) is provided, which is user-operable and rotatable about a longitudinal axis (207), A piston rod (42, 240) is configured to advance proximal in the axial direction to deliver a set dose, It has a dispensing member (330) for defining the axial advance of the piston rod (42, 240) when delivering a set dose, The dispensing member (330) is axially movable along the longitudinal axis (207) during dose setting, and is capable of rotational movement about the longitudinal axis (207). The administration member (330) is rotatably fixed to the dose setting members (31, 290) during dose setting. The administration member (330) is equipped with a zero-dose stop unit (340), The zero-dose stop unit (340) is configured to engage with the zero-stop feature unit (196) to restrict the movement of the administration member (330) relative to the housing (3, 43, 210, 221, 223, 226) when setting the zero dose. The zero-stop feature section (196) is located in the housing (3, 43, 210, 221, 223, 226) of the drug delivery device (10, 200, 220, 222, 225).

[0485] 33. The drug delivery device (10, 200, 220, 222, 225) according to Embodiment 32, wherein the administration member (330) is rotatable relative to the dose setting members (31, 290) during dose delivery.

[0486] 34. The zero-dose stop unit (340) engages with the zero-stop feature unit (196) in a contact plane that is angled with respect to a radial plane perpendicular to the longitudinal axis (207), For example, the drug delivery device according to one of embodiments 32 and 33 (10, 200, 220, 222, 225) has a contact plane 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 section (340) of the administration member (330) includes a stop surface configured to abut against a corresponding stop surface of the housing (3, 43, 210, 221, 223, 226).

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

[0489] 1 cap 2 Cartridge holders 3. Outer housing 3a Window 4 needles 5 Hubs 6 Cannulas 8 cartridges 8a Sealing means 9 pistons 10 Further drug delivery devices 30. Mechanism of Administration 31 Dosage setting member 32 Clutch component 32. Ridge section 33 snap elements 33a Clutch element 33c Flexible Arm 33d protrusion 33f Further protrusions 34 connectors 34a Clutch element 34b Ridge 35. Dosage selector member 35a Dose stop section 35b Maximum Stop Feature Section 35c Minimum Stop Feature Section 36 nuts 37 Spline connections 38 Dosage Sleeves 40 Optical Markers 41 Drivers 42 Piston Rod 42a Disk 43 Piston Guide 60 External thread 61 Dosage button 67 threads 63 Stopping Feature Section 64 Protrusion 81 Drug Section 82 Ring Rim 83 Distal surface 85 Annular detent 90 Rotation biasing member 100 Reset Mechanism 110 Reset elements 111 Gripping Zone 112 Receptor regions 113 Inner self 114 Opening 115 Cartridge Cavity 116 Guide Structure 116a Front 116b Rear 117 Contact structure 119 Stop part 120 Engagement feature part 130 Joint part / insert 134 Binding Site 135 Engagement feature 136 Notches 137 First locking structure 138 Protrusion 139 slots 139a recess 140 Second locking structure 150 biasing elements 160 counterweights 161 Base 162 Top surface 163 Proximal projection 164 Front 165 Distal projection 170 Seat area 171 Longitudinal stopping element 172 Circumferential stop element 173 Longitudinal stopping element 175 Stopping surface 180 Inner Housing 180a Window 181 Proximal portion 182 Distal portion 183 Inner sleeve 184 Tappet 185 Dosage thread 186 drive screw threads 187 Groove 188 Further grooves 189 Housing cavity 190 Maximum Stop Feature Section 191 Hook 192 Restriction surface 193 Depression 194 Protrusion 195 Bulge 196 Zero Stop Feature Section 197 Zero stopping surface 198 Longitudinal Slots 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 Colors 214 detents 216 detents 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 mechanism 234 Clutch Mechanism 235 Part 1 236 Part 2 237 Clutch Mechanism 238 Part 1 239 Part 2 240 Piston Rod 241 threads 242 Plunger Disc 243 Stopping Feature Section 244 disk connectors 250 nuts 251 Proximal portion 252 Distal portion 253 Proximal projection 254 Longitudinal grooves 255 Annular detent 256 threads 270 Clutch component 271 Longitudinal ridge section 273 Clutch elements 274 Proximal portion 275 Distal portion 277 connections 278 Snap Hook 279 First ridge section 280 Second ridge section 290 Dosage setting member 292 Elastic elements 294 Clutch elements 295 Depression 296 Opening 297 First longitudinal groove 298 Second longitudinal groove 308 Biasing member 310 Dosage selector member 311 Distal portion 312 Functional Features 314 Contact surface 315 Ridge section 316 Further raised sections 317 Proximal portion 318 Connector 319 Flexible member 319a Protrusion 320 detents 322 Interior wall 323 Opening 330 Dosage component 331 Optical Markers 332 Proximal portion 333 Distal portion 334 Screw-type connection 335 External thread 336 Clutch elements 337 Maximum dose stop part 338 Stopping surface 340 Zero-dose stop unit 341 Groove 343 Connector 344 Ring-shaped ridge section 346 Distal end face 350 Drivers 351 Proximal portion 352 Screw-type connection 353 threads 354 connections 356 Flexible Arm 358 Front 359 Distal portion 360 spline 370 First bearing element 371 Distal disk 372 Holder 373 Proximal Disk 375 balls 380 Second bearing element 402 Needle Connector 404 connector 405 Contact surface 406 biasing elements 407 Contact surface 408 Stop part 409 Ridge section 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 Second connection means 440 Third distribution unit 442 Third cartridge holder 444 Third connection means 450 Contact feature section 501 Ridge section 502 Valley 510 Connection means 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 is the second height CD2's second core diameter D2 Second outer diameter A2 Second Angle P3, third pitch w3 Third width h3 Third height CD3's third core diameter D3 Third outer diameter A3 Third Angle

Claims

1. Drug delivery devices (10, 200, 220, 222, 225), A housing (3, 43, 210, 221, 223, 226) having a longitudinal axis (207), To set the dose to be delivered by the drug delivery device (10, 200, 220, 222, 225), a dose setting member (31, 290) is provided, which is user-operable and rotatable about the longitudinal axis (207), A piston rod (42, 240) is configured to advance proximal in the axial direction in order to deliver the set dose, The device includes a dispensing member (330) for defining the axial advance of the piston rods (42, 240) when delivering the set dose, The administration member (330) is movable axially along the longitudinal axis (207) during dose setting, and is capable of rotational movement about the longitudinal axis (207). The administration member (330) is fixed in a rotational direction relative to the dose setting members (31, 290) during dose setting. The administration member (330) is equipped with a maximum dose stop unit (337), The maximum dose stop unit (337) is configured to engage with the maximum stop feature unit (190) to restrict the movement of the administration member (330) relative to the housing (3, 43, 210, 221, 223, 226) when the maximum dose is set. The maximum stop characteristic section (190) is provided in the housing (3, 43, 210, 221, 223, 226), The drug delivery device (10, 200, 220, 222, 225) includes a dose setting mechanism (232) for defining the rotational dose position of the dose setting member (31, 290) relative to the housing (3, 43, 210, 221, 223, 226), The dose setting members (31, 290) are connected to the housing (3, 43, 210, 221, 223, 226) via dose selector members (35, 310), The dose selector members (35, 310) are fixed to the housing (3, 43, 210, 221, 223, 226) in the rotational direction and are movable in the axial direction. The dose selector members (35, 310) are configured to move distally from the housing (3, 43, 210, 221, 223, 226), The dose-determining mechanism (232) operates between the dose selector members (35, 310) and the dose setting members (31, 290), or The dose-determining mechanism (232) is a drug delivery device (10, 200, 220, 222, 225) that operates between the dose selector member (35, 310) and the administration member (330).

2. The drug delivery device (10, 200, 220, 222, 225) according to claim 1, wherein the administration member (330) is rotatable relative to the dose setting members (31, 290) during dose delivery.

3. The drug delivery device (10, 200, 220, 222, 225) according to claim 1 or 2, wherein the administration member (330) is screw-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. The drug delivery device (10, 200, 220, 222, 225) according to claim 1 or 2, wherein the maximum dose stop section (337) comprises a stop surface (338) configured to abut axially against the maximum stop feature section (190) of the housing (3, 43, 210, 221, 223, 226) when setting the maximum dose.

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

6. The drug delivery device (10, 200, 220, 222, 225) according to claim 4, wherein the stopping surface (338) is an annular surface surrounding the longitudinal axis (207).

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

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

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

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

11. The maximum stop feature portion (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) according to claim 1 or 2, the drug delivery device (10, 200, 220, 222, 225).

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

13. The administration member (330) includes a zero-dose stop unit (340), The zero-dose stop unit (340) is configured to engage with the zero-stop feature unit (196) to restrict the movement of the administration member (330) relative to the housing (3, 43, 210, 221, 223, 226) when the administration member (330) reaches the zero-dose position. The drug delivery device (10, 200, 220, 222, 225) according to claim 1 or 2, wherein the zero-stop feature section (196) is provided in the housing (3, 43, 210, 221, 223, 226).

14. The drug delivery device according to claim 13 (10, 200, 220, 222, 225), 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. The drug delivery device according to claim 14 (10, 200, 220, 222, 225), wherein the contact plane is oriented perpendicular to the radial plane.

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

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

18. The drug delivery device (10, 200, 220, 222, 225) according to claim 17, wherein the structural element comprises a dose thread (185) that engages with the administration member (330) in a screw-like manner.

19. The drug delivery device (10, 200, 220, 222, 225) according to claim 1 or 2, wherein the dose selector members (35, 310) are fixed in the axial direction with respect to the administration member (330) during dose setting.

20. The dose selector members (35, 310) are connected to the housing (3, 43, 210, 221, 223, 226) via connections (187, 188, 315, 316) that enable the dose selector members (35, 310) to be mounted on the housing (3, 43, 210, 221, 223, 226) only in a rotational direction that ensures the dose setting member (31, 290) is set to the dose position when it engages with the maximum stop feature portion (190) of the maximum dose stop portion (337). The drug delivery device (10, 200, 220, 222, 225) according to claim 1 or 2, wherein the connections (187, 188, 315, 316) include spline connections that allow axial movement of the dose selector member (35, 310) relative to the housing (3, 43, 210, 221, 223, 226) and prevent rotational movement.

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

22. The drug delivery device according to claim 20 (10, 200, 220, 222, 225), wherein the spline connection comprises a set of coding splines, each of which has different dimensions in width and / or height.

23. The drug delivery device (10, 200, 220, 222, 225) according to 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. The drug delivery device (10, 200, 220, 222, 225) according to claim 1 or 2, wherein the administration member (330) is coupled to the piston rod (42, 240) via a forward mechanism that converts the axial movement of the administration member (330) into axial forward movement of the piston rod (42, 240) during dose delivery, and as a result, the axial movement of the administration member (330) during dose delivery causes the piston rod (42, 240) to advance proximal in the axial direction.

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

26. The piston rods (42, 240) are fixed to the housing (3, 43, 210, 221, 223, 226) in the rotational direction. The forward mechanism includes nuts (36, 250) that connect the piston rod (42, 240) and the dispensing member (330), The nuts (36, 250) are screw-type connected to the piston rods (42, 240), During dose setting, the nuts (36, 250) are fixed to the dispensing member (330) in a rotational direction and are rotatable relative to the housing (3, 43, 210, 221, 223, 226). During dose delivery, the nuts (36, 250) are rotatable relative to the dispensing member (330) and fixed in the rotational direction relative to the housing (3, 43, 210, 221, 223, 226), as described in claim 24, for the drug delivery device (10, 200, 220, 222, 225).

27. Drug delivery devices (10, 200, 220, 222, 225), A housing (3, 43, 210, 221, 223, 226) having a longitudinal axis (207), To set the dose to be delivered by the drug delivery device (10, 200, 220, 222, 225), a dose setting member (31, 290) is provided, which is user-operable and rotatable about the longitudinal axis (207), A piston rod (42, 240) is configured to advance proximal in the axial direction in order to deliver the set dose, The device includes a dispensing member (330) for defining the axial advance of the piston rods (42, 240) when delivering the set dose, The administration member (330) is movable axially along the longitudinal axis (207) during dose setting, and is capable of rotational movement about the longitudinal axis (207). The administration member (330) is fixed in a rotational direction relative to the dose setting members (31, 290) during dose setting. The administration member (330) includes a zero-dose stop unit (340), The zero-dose stop unit (340) is configured to engage with the zero-stop feature unit (196) to restrict the movement of the administration member (330) relative to the housing (3, 43, 210, 221, 223, 226) when setting the zero dose. The zero-stop feature section (196) is provided in the housing (3, 43, 210, 221, 223, 226), The drug delivery device (10, 200, 220, 222, 225) includes a dose setting mechanism (232) for defining the rotational dose position of the dose setting member (31, 290) relative to the housing (3, 43, 210, 221, 223, 226), The dose setting members (31, 290) are connected to the housing (3, 43, 210, 221, 223, 226) via dose selector members (35, 310), The dose selector members (35, 310) are fixed to the housing (3, 43, 210, 221, 223, 226) in the rotational direction and are movable in the axial direction. The dose selector members (35, 310) are configured to move distally from the housing (3, 43, 210, 221, 223, 226), The dose-determining mechanism (232) operates between the dose selector members (35, 310) and the dose setting members (31, 290), or The dose-determining mechanism (232) is a drug delivery device (10, 200, 220, 222, 225) that operates between the dose selector member (35, 310) and the administration member (330).

28. The drug delivery device (10, 200, 220, 222, 225) according to claim 27, wherein the administration member (330) is rotatable relative to the dose setting members (31, 290) during dose delivery.

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

30. The drug delivery device (10, 200, 220, 222, 225) according to claim 27 or 28, wherein the zero-dose stop portion (340) of the administration member (330) includes a stop surface configured to contact a corresponding stop surface of the housing (3, 43, 210, 221, 223, 226).

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

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