Assembly for a drug delivery device and drug delivery device

Abstract

A component for a drug delivery device is provided, the component comprising: a housing (10) having a proximal end and a distal end; a dose setting member (80) rotatable relative to the housing for a dose setting operation in order to set a dose of drug to be delivered, wherein a) the component further comprises a tracking member (50), wherein the tracking member is operably coupled or coupleable to the dose setting member, or wherein b) the dose setting member is a tracking member, wherein the component further comprises a guide track (150), wherein the guide track is configured to form a guide interface to guide and / or drive movement of the tracking member, wherein the component is configured such that the tracking member is displaced towards an axial tracking member end position during the dose setting operation, wherein the distance by which the tracking member is displaced towards the axial tracking member end position depends on the size of the set dose.

Description

Background Art

[0001] The present disclosure relates to an assembly for a drug delivery device and a drug delivery device, in particular a device comprising the assembly.

[0002] Drug delivery devices often include an end-of-content tracker mechanism that prevents the device from being used in a delivery operation that attempts to deliver an amount of drug that exceeds the amount of drug available in the reservoir. Typically, these mechanisms are designed to prevent the setting of a dose that exceeds the amount of drug remaining in the reservoir. Summary of the invention

[0003] It is an object of the present disclosure to provide a novel assembly for a drug delivery device, which helps to provide an improved drug delivery device. Furthermore, a drug delivery device should be provided, preferably a device comprising said assembly.

[0004] This object is achieved by the subject matter of the independent claims. The dependent claims relate to advantageous embodiments and improvements. However, it should be noted that the disclosure is not limited to the claims and may comprise other embodiments that are broader than the embodiments defined in the claims. Of course, the features disclosed in connection with the different embodiments may also be combined with each other and / or with the features of other embodiments. However, the scope of protection of the invention is defined by the appended claims.

[0005] In an embodiment, the assembly for the drug delivery device includes a housing having a proximal end and a distal end. The assembly also includes a dose setting member. The dose setting member is preferably rotatable relative to the housing for a dose setting operation, so as to set a dose of the drug to be delivered (e.g., by the drug delivery device), and / or for delivering the set dose in a subsequent dose distribution or dose delivery operation. In order to set the dose, the dose setting member can be rotatable in one rotation direction, for example, rotatable in an increasing direction away from the initial position toward the dose setting position to increase the size of the set dose. When in the initial position, rotation in the opposite direction of the increasing direction can be prevented. When a dose of a specific size has been set (i.e., in the dose setting position), rotation in the opposite direction of the increasing direction can be allowed to reduce the set dose (e.g., in case it does not match the expected size). In addition, the set dose can be allowed to be further increased from the dose setting position by continuing to rotate in the increasing direction (e.g., until the maximum settable dose). The dose setting member can present a user interface of the assembly. Therefore, the user interface can be arranged to be directly touched by the user for operating the assembly.

[0006] The assembly further comprises a tracking member. The tracking member may be a member of the content ending tracker mechanism mentioned further above. The position (particularly the axial position) of the tracking member relative to the housing may indicate the remaining total dose that can still be set and delivered using the assembly.

[0007] The tracking member may be a different member from the dose setting member. In other words, the tracking member may be operably coupled or connectable to the dose setting member (e.g. directly or indirectly). In particular, a rotation of the dose setting member may be converted into a movement of the tracking member relative to the housing, in particular an axial movement. The tracking member may be rotated relative to the housing during the axial movement or rotationally locked relative to the housing. Alternatively, the dose setting member itself may be the tracking member. Thus, one member may act as both a setting member and a tracking member.

[0008] The dose setting member may be unitary or it may have a plurality of parts which are conveniently rigidly connected to each other. If the dose setting member has a plurality of parts, these parts are conveniently used as a single member during operation of the assembly, in particular during a dose setting operation, a dose correction operation, a reset operation and / or a dose delivery operation.

[0009] The assembly also includes a guide track. The guide track is conveniently configured to form or define a guide interface to guide and / or drive movement of the tracking member (e.g., to guide and / or drive movement relative to the housing and / or another member of the assembly, wherein the member may include the guide track). A guide interface may be established between the guide track and an interface feature that mechanically cooperates with the guide track. One of the interface feature and the guide track may be disposed on the tracking member. The other of the interface feature and the guide track may be disposed on another member of the assembly or the housing. The guide track may be a spiral track or a thread.

[0010] The assembly is configured such that the tracking member is displaced towards a preferably axial tracking member end position (e.g. the position of the tracking member relative to the housing or the other member of the assembly) during the dose setting operation. The distance by which the tracking member is displaced towards the axial tracking member end position may be dependent on (e.g. proportional to) the size of the dose set during the dose setting operation.

[0011] When the tracking member has reached the tracking member end position, the dose setting member may be prevented from further rotation in a direction that would increase the size of the set dose (e.g. by the tracking member abutting an axial and / or rotational end stop). When the tracking member is in its end position, a reduction in the set dose is preferably still allowed.

[0012] By using a dose setting member as tracking member or a tracking member operably coupled to a dose setting member, the tracking member can be arranged relatively close to the outer surface of the assembly. Thus, once the tracking member is in its end position, a load applied by the user to the tracking member in an attempt to increase the set dose (which is, of course, blocked by the tracking member) can be transferred to a component having a larger diameter than a component arranged further inside the assembly. For example, the load can be reacted by the housing. Due to the larger diameter, the force acting on or by the tracking member (which needs to be reacted to block further rotation of the tracking member) can be smaller than if the tracking member acts in an area with a smaller diameter inside the assembly.

[0013] The dose setting member is conveniently provided to be manipulated by a user for setting a dose. Thus, the dose setting member preferably provides a portion of an outer surface of the assembly or drug delivery device. If the tracking member is close to the outer surface, the guiding interface may also be so. Thus, the tracking member may be guided by the interface at a relatively large diameter compared to components arranged further inside the assembly. This may be advantageous because the tracking member may be arranged very close to the portion of the assembly where the user applies force to set a dose (i.e. the outer surface of the dose setting member accessible from outside the device or assembly).

[0014] In an embodiment, during a dose setting operation, the dose may be incrementally varied (e.g., increased or decreased) by an integer multiple of a unit increment. The number of different doses that may be set in a dose setting operation and delivered in a dose delivery operation may be greater than or equal to one of the following values: 5, 10, 15. Alternatively or additionally, the number of different doses that may be set in a dose setting operation and delivered in a dose delivery operation may be less than or equal to one of the following values: 20, 19, 18, 17, 16.

[0015] In an embodiment, the axial tracking member end position is defined by a guide track. For example, an angular end surface of the guide track may define an end stop surface that is abutted by a corresponding surface of the interface feature when the tracking member has reached the end position and thus further rotation in a direction to increase the set dose is no longer possible.

[0016] In an embodiment, the assembly is configured such that a relative position of the tracking member with respect to a position of an end of the axial tracking member is constant during the dose delivery operation.

[0017] In an embodiment, the axial tracking member end position is defined by an end stop which is rotationally and / or axially secured to the housing (eg during a dose setting operation and / or a dose delivery operation).The end stop may be separate from the guide track and / or the interface feature.

[0018] In an embodiment, the assembly includes another component. The other component as a dose setting component can be part of the dose setting and drive mechanism of the assembly. The other component can be a component operably connected to an energy storage component, which is designed to store energy due to the force provided by the user during the dose setting operation. The energy storage component can be a spring (such as a drive spring, such as a torsion spring). The spring can be designed to provide the force required for the dose delivery operation, which is performed after the dose has been set so as to deliver the set dose. For example, the other component can be a dose indication component (such as a number sleeve).

[0019] In an embodiment, the dose setting member may be operably coupled or connectable to the other member, in particular during the dose setting operation, so as to transfer force from the dose setting member to the other member. The coupling may be performed via a coupling mechanism. The coupling mechanism may be configured to couple, preferably releasably couple, the other member to the dose setting member, for example during the dose setting operation. The coupling mechanism may be a setting coupling mechanism. The coupling mechanism may include a coupling force transfer interface, in particular during the dose setting operation, via which force is transferred from the dose setting member to the other member. For this purpose, coupling features that are locked (e.g., locked in a rotational manner) relative to the dose setting member and the other member may be adjacent. The coupling feature of the dose setting member may be arranged on a member (e.g., an activation member) that is locked in a rotational manner to the dose setting member, which member will be discussed below. The coupling feature of the other member may be arranged on the other member. Therefore, when the other member and the dose setting member are coupled, the first coupling feature of the activation member and the second coupling feature of the other member may be adjacent. The coupling may be released by relative axial movement between the first coupling feature and the second coupling feature. During a dose setting operation, the dose setting member may be rotationally locked to the other member, in particular by a coupling mechanism. The rotation lock may be operable in both rotational directions so that the other member follows the rotational movement of the dose setting member in both rotational directions (e.g. to increase and decrease the size of the set dose).

[0020] For a dose delivery operation, the coupling between the further component and the dose setting component may be released. When the coupling is released, there may be no force transfer from the dose setting component to the further component and / or vice versa. When the coupling is released, the further component may be allowed to rotate relative to the dose setting component.

[0021] In an embodiment, force is transferred from the dose setting member to the tracking member via a tracking member force transfer interface. This interface may be a guide interface or a different interface (such as a spline interface). The dose setting member may be directly coupled to the tracking member via this interface. Alternatively, the dose setting member may be indirectly coupled to the tracking member via this interface (e.g., via an activation member to be discussed further below).

[0022] In an embodiment, the tracking member force transmission interface is arranged closer to an outer surface of the dose setting member (in particular a surface configured to be touched by a user) than the coupling force transmission interface, in particular as seen along a force transmission path from the outer surface to the respective force transmission interface. In other words, the force transmission path from the outer surface of the dose setting member to the coupling force transmission interface may be longer than the force transmission path from the outer surface of the dose setting member to the tracking member force transmission interface.

[0023] In an embodiment, the tracking member force transfer interface is arranged proximally relative to the coupling force transfer interface. In other words, the tracking member force transfer interface can be arranged closer to the proximal end of the assembly or device than the coupling force transfer interface.

[0024] Thus, a force transmission to the tracking member can be achieved close to the proximal end. Furthermore, forces acting on the tracking member in the end position can be reacted or transmitted to the housing faster than if the tracking member was arranged further away from the dose setting member (as seen along the force transmission path) or further away from the proximal end. Furthermore, forces do not act on the coupling mechanism, which is advantageous because a user trying to increase the dose beyond the limit defined by the end position of the tracking member may apply considerable forces which may break or damage components of the assembly.

[0025] In an embodiment, the guide track is offset radially outwardly relative to the first coupling feature and / or the second coupling feature, for example at least in a dose setting operation.

[0026] In an embodiment, the guide track is proximally offset relative to the first coupling feature and / or the second coupling feature, for example at least in a dose setting operation.

[0027] In an embodiment, the assembly further comprises a piston rod. The piston rod may be a lead screw. The piston rod may be configured to be displaced in a distal direction relative to the housing towards a distal position for delivering a previously set dose in a dose delivery operation. The distal position may be a position where further dose delivery operations and / or further dose setting operations are no longer possible. Thus, when the piston rod is in the distal position, the piston rod can no longer be displaced in a distal direction or away from the proximal end.

[0028] In an embodiment, the assembly includes a drive member. The drive member can be engaged to the piston rod so as to transfer force to the piston rod for a delivery operation. The drive member can be rotationally locked to the piston rod. The force transferred to the piston rod can be or can include a force transferred from a user to the piston rod and / or a force transferred from an energy storage member (such as a spring) to the piston rod. If an energy storage member is used, the energy stored in the member can be increased during a dose setting operation. Therefore, the user can provide force for a delivery operation during a dose setting operation.

[0029] In an embodiment, the length of the guide track is a feature of the distance that the piston rod can be axially displaced relative to the housing from the proximal initial position to the distal position. Thus, the length of the guide track can be a feature of the entire displacement distance that can be used to displace the piston rod to perform a delivery operation. In the initial position, the reservoir of the drug delivery device may still be full, without the drug being dispensed from the reservoir. When the piston rod is in the distal position, the drug delivery device or reservoir is considered empty.

[0030] In an embodiment, the distance of the tracking member from the axial end position of the tracking member before starting the dose setting operation may be determined by (eg proportional to) the distance between the current position of the piston rod and the distal end position of the piston rod.

[0031] In an embodiment, the relative position between the tracking member and the axial tracking member end position is constant during the dose delivery operation.Alternatively or additionally, there may be no relative movement between the guide track or interface feature and the tracking member during a dose delivery operation.

[0032] In an embodiment, the tracking member is arranged relative to the housing such that the tracking member axially overlaps the dose setting member. Thus, as seen along a longitudinal axis that may extend from a proximal end to a distal end of the housing, there is an axial position where, when viewed in a radial direction from the axial position, a segment of the tracking member and a segment of the dose setting member are arranged. A segment of the housing may be arranged between the dose setting member and the tracking member.

[0033] The arrangement of the tracking member relative to the housing or other parts or components (which is specified above or further below) may be present in an initial position of the tracking member and an axial tracking member end position or in only one of these positions (such as being present in the initial position or in the axial tracking member end position). The arrangement of the tracking member relative to the housing or relative to other parts or components (which is specified above or further below) may be present at least in a dose setting operation (such as being present only in a dose setting operation) or in a dose setting operation and a dose delivery operation.

[0034] In an embodiment, the tracking member is arranged between a surface of the housing and a surface of the dose setting member.The tracking member may be arranged between an outer surface of the housing and an inner surface of the dose setting member.

[0035] In an embodiment, the housing defines a portion of the outer surface of the assembly. The cartridge unit may be fastened to the housing at the proximal end of the housing. The housing may have a tubular shape and / or may house additional components of the dose setting and drive mechanism, such as a drive spring, a drive member and / or a piston rod.

[0036] In an embodiment, the dose setting member is axially locked to the housing but is rotatable relative to the housing for the dose setting operation. In this case, the axial position of the dose setting member relative to the housing does not change when a dose setting operation is being performed. The dose setting member may be permanently axially secured to the housing.

[0037] In an embodiment, in particular if the dose setting member is a tracking member, the dose setting member may be axially displaced relative to the housing during a dose setting operation by a distance that is characteristic of the size of the currently set dose.

[0038] In an embodiment, the tracking member is arranged in the proximal region of the housing. This helps to have a short force transmission path between the dose setting member and the tracking member. Specifically, the tracking member can be arranged closer to the proximal end of the housing than the distal end of the housing.

[0039] In an embodiment, the dose setting member is engaged to the housing via the guide track. In particular, this is useful if the dose setting member is a tracking member.

[0040] In an embodiment, the dose setting member is configured to be touched by a user (e.g. for a dose setting operation, such as for performing a dose setting operation). In particular, a radial surface of the dose setting member may be touched by a user for rotating the dose setting member relative to the housing in a dose setting operation. In other words, the dose setting member may provide a portion of an outer surface of the component.

[0041] In an embodiment, the assembly includes an activation member. The activation member may be configured to be operated to perform a dose delivery operation, for example, for delivering a previously set dose (such as a dose set in a dose setting operation). The activation member may be rotationally locked to the dose setting member. Thus, the activation member and the dose setting member may rotate together, regardless of the rotational direction relative to the housing rotation. The activation member may be axially movable relative to the dose setting member (e.g., in a distal direction and / or in order to initiate a dose delivery operation). The activation member may provide a portion of an outer surface of the assembly.

[0042] In an embodiment, the axial position of the activation member relative to the housing is constant during a dose setting operation. The proximal surface of the activation member may form the proximal end of the assembly or the entire device. Thus, the length of the assembly does not change significantly or at all during a dose setting operation.

[0043] In an embodiment, the activation member protrudes proximally from the dose setting member. The activation member may protrude from the dose setting member regardless of the position of the tracking member relative to the housing. During dose setting, for example if the dose setting member is a tracking member, the distance between the proximal end of the dose setting member and the proximal end of the activation member may decrease, in particular by an amount that is characteristic of the currently set dose. Therefore, the length by which the activation member protrudes proximally from the dose setting member should be greater than the axial distance between the axial tracking member end position and the initial position of the dose setting member.

[0044] In an embodiment, the activation member is configured to be touched and / or moved by the user for the dose delivery operation (e.g., for starting and / or for performing the dose delivery operation). The activation member can be moved from a first position to a second position, for example, relative to the housing and / or axially (e.g., only axially). The first position can be offset proximally relative to the second position. The assembly can be configured so that during the movement of the activation member from the first position to the second position, the coupling mechanism is released. In other words, during the movement of the activation member from the first position to the second position, the other member and the dose setting member can be decoupled from each other (e.g., rotationally). Therefore, in the second position, another member can be allowed to rotate relative to the dose setting member. Alternatively or additionally, the dose setting member can be locked in rotation relative to the housing. Therefore, in the second position of the activation member, the dose setting member and the other member can be uncoupled, and / or the dose setting member can be locked in rotation relative to the housing. When the activation member is in the second position, the activation member can be biased toward the first position (e.g., by an elastic member). Therefore, the first position can be the normal position of the activation member.

[0045] Preferably, a rotational lock between the dose setting member and the housing is established before releasing the coupling mechanism. This prevents that the user can change the rotational position of the dose setting member (which may have a direct or indirect effect on the position of the tracking member relative to the end position of the tracking member) when the coupling mechanism has been released. The dose setting member may be rotationally locked relative to the housing by a rotational lock, the locking feature being established between a locking feature of the dose setting member and a locking feature provided on the housing.

[0046] In an embodiment, the tracking member is arranged between a region where the dose setting member is axially locked relative to the housing and the proximal end of the housing.

[0047] In an embodiment, the tracking member is axially locked relative to the housing when the activation member moves from the first position to the second position.Alternatively, the tracking member may follow the axial movement of the activation member relative to the housing from the first position to the second position.

[0048] In an embodiment, the tracking member is joined to at least one member defining at least a portion of the outer or external surface of the assembly. Preferably, the at least one member is a member other than the housing (e.g. a dose setting member and / or an activation member). The tracking member may be joined to multiple members defining at least a portion of the outer or external surface of the assembly, e.g. to two members. The two members may include the housing.

[0049] In an embodiment, the tracking member is engaged to the dose setting member.Additionally, the tracking member may be engaged to the housing.

[0050] In an embodiment, the tracking member is coupled to the activation member. Additionally, the tracking member may be coupled to the housing.

[0051] In an embodiment, the guide track is provided on the housing, on the dose setting member, on the activation member or on the tracking member. The interaction feature for establishing the guide interface may be arranged on the tracking member or on a member to which the tracking member engages. Conveniently, the guide track and the interaction feature are arranged on different components or members.

[0052] In an embodiment, the guiding interface is established between the tracking member and the housing, between the tracking member and the activation member, or between the tracking member and the dose setting member.

[0053] In an embodiment, the tracking member is a last dose member and / or a nut member (such as a last dose nut).

[0054] In an embodiment, the assembly includes an energy storage member (e.g., a spring). The energy storage member can be configured to store energy for use in a dose delivery operation. During a dose setting operation, the energy stored in the energy storage member can be increased (e.g., by energy provided by a user).

[0055] In an embodiment, a drug delivery device is provided, wherein the device preferably includes components as discussed above. The drug delivery device also includes a reservoir for holding the drug and / or a reservoir holder provided to hold the reservoir for holding the drug. The reservoir can be a cartridge. The amount of drug conveniently held in the reservoir is sufficient to deliver multiple doses (preferably, even if a maximum dose is set each time). The device can be an injection device (e.g., a pen injector). The device can be a reusable device or a disposable device. The device can be based on a needle. The dose delivery operation can be driven in part or in whole by the energy provided by the energy storage member.

[0056] Features disclosed in connection with different embodiments may be combined with each other. For example, features disclosed for the drug delivery device also apply to the assembly, and vice versa.

[0057] "Distal" is used herein to specify a direction, end or surface that is arranged or will be arranged to face the distribution end of a component, a drug delivery device or its parts and / or is directed or will be directed away from or away from the proximal end. On the other hand, "proximal" is used to specify a direction, end or surface that is arranged or will be arranged to face the distribution end or distal end of a component, a drug delivery device or its parts. The distal end can be the end closest to the distribution end and / or farthest from the proximal end. The proximal end can be the end farthest from the distribution end. The proximal surface can be away from the distal end and / or face the proximal end. The distal surface can face the distal end and / or away from the proximal end.

[0058] In a particularly advantageous embodiment, there is provided an assembly for a drug delivery device, the assembly comprising:

[0059] - a housing having a proximal end and a distal end,

[0060] - a dose setting member rotatable relative to the housing for a dose setting operation in order to set a dose of drug to be delivered, wherein

[0061] a) The assembly further comprises a tracking member, wherein:

[0062] The tracking member is operably coupled or coupleable to the dose setting member, or wherein,

[0063] b) the dose setting member is a tracking member,

[0064] wherein the assembly further comprises a guide track, wherein the guide track is configured to form a guide interface to guide and / or drive the movement of the tracking member, wherein the assembly is configured such that the tracking member is displaced toward an axial tracking member end position during the dose setting operation, wherein a distance by which the tracking member is displaced toward the axial tracking member end position depends on a size of the set dose.

[0065] Further features, advantages and conveniences will become apparent from the following description of exemplary embodiments taken in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0066] FIG. 1 shows a perspective view of one embodiment of a drug delivery device.

[0067] FIG. 2 shows an exploded view of components of the device of FIG. 1 .

[0068] Figure 3a shows a cross-sectional view of the proximal end of the device of Figure 1 in a dose set state.

[0069] Fig. 3b shows a cross-sectional view of the proximal end of the device of Fig. 1 in a dose dispensing state.

[0070] FIG. 4 shows a detail of a device according to another embodiment in a cross-sectional view.

[0071] Fig. 5a shows a cross-sectional view of a detail of a device according to yet another embodiment of the invention.

[0072] FIG. 5b shows a detail of the embodiment of FIG. 5a .

[0073] 6a and 6b illustrate exemplary embodiments of drug delivery devices.

[0074] 7a and 7b illustrate another exemplary embodiment of a drug delivery device.

[0075] 8a to 8d illustrate another exemplary embodiment of a drug delivery device. DETAILED DESCRIPTION

[0076] In the accompanying drawings, the same elements, elements having the same element function, and elements of the same type may be provided with the same reference numerals. In addition, it should be understood that the accompanying drawings only illustrate some embodiments of the present disclosure. The disclosed concepts may also be applicable to designs of drug delivery devices that are different from those disclosed below.

[0077] Fig. 1 shows a drug delivery device in the form of an injection pen. The device has a distal end (left end in Fig. 1) and a proximal end (right end in Fig. 1). The component parts of the drug delivery device are shown in Fig. 2. The drug delivery device includes a body or housing 10, a cartridge holder 20, a lead screw (piston rod) 30, a drive sleeve or driver 40, a tracking member (nut) 50, a dose indicator (number sleeve) 60, an activation member (button) 70, a dose setting member (dial grip or dose selector) 80, a torsion spring 90, a cartridge 100, a metering element 110, a coupling plate 120, a coupling spring 130 and a bearing 140. The needle arrangement (not shown) with a needle hub and a needle cover can be set as an additional component, which can be exchanged. All components are concentrically positioned around the common main axis I (Fig. 3b) of the mechanism or device.

[0078] The housing 10 or body is a generally tubular housing element having a proximal end of, for example, an increased diameter. The housing 10 provides positioning for a liquid drug or medication cartridge 100 and a cartridge holder 20. As shown in FIGS. 1 and 2 , the housing includes a first window 11 a and a second window (or lens) 11 b incorporated into the housing body, for example, by double injection molding. The windows 11 a, 11 b may be molded in a translucent (and preferably transparent) material during a first injection, and the outer cover of the housing is molded in an opaque material during a second injection.

[0079] In the embodiment of Fig. 1 to Fig. 3b, the housing includes an insert 12 as an integral part, which is positioned as an inner wall near the distal end of the housing. The insert 12 can be molded in a translucent material. As an alternative, the insert or part thereof can be formed in an opaque material or formed as a separate component part as depicted in the embodiment of Fig. 4.

[0080] The insert 12 is a cup-shaped component part having a side wall 13 and a tube 14 extending through the insert 12, thereby forming an annular space therebetween. An arm 15 extends radially outward from the side wall 13. A bottom wall 16 connects the side wall 13 and the tube 14 on the distal side of the insert 12, while the opposite proximal side is open. The insert 12 has various interfaces. For example, the tube 14 of the insert 12 includes an internal thread 17 that engages the piston rod 30. In addition, the radial space between the tube 14 and the outer side wall 13 can provide a bearing area for receiving the drive spring 90 and the coupling spring 130. Further, spline teeth 18 are provided on the insert 12, engaging with corresponding spline teeth 41 at the distal end of the drive sleeve 40. The teeth 18 interact with the drive sleeve 40 so as to rotationally couple and decouple the drive sleeve from the housing 10.

[0081] In the embodiment of Fig. 4, the insert is an integral part of the inner shell portion of the housing, which is partially surrounded by the outer shell portion of the housing. The shell portions can be formed by two consecutive injection molding shots so that the shell portions are permanently attached to each other. For example, the inner shell portion is formed of a transparent or translucent material, while the outer shell portion is formed of an opaque material.

[0082] In the embodiment of FIGS. 5a and 5b , the insert 12 is partially formed as a single component part with the housing 10 and partially formed as a separate component part 19. The cup-shaped body 13 and the threaded tube 14 with an annular space for the compression spring are integrally formed with the housing 10 and connected to the housing via arms 15, while the coupling feature 18 for rotationally constraining the drive sleeve 40 is a separate annular component part 19, which is axially and rotationally constrained to the housing 10. Therefore, according to the embodiment of FIGS. 5a and 5b , the annular insert part 19 does not have the threads 17 as an integral part. As shown in more detail in FIG. 5b , the annular insert part 19 includes axially oriented splines 19a on the inner surface in order to rotationally constrain the drive sleeve 40. The annular insert part 19 also includes arms or splines 19b located on its outer surface for rotationally retaining in the housing 10. Further, a number of hook-shaped arms 19c are provided to form a snap-fit ​​clamp for axially retaining the annular insert part 19 in the housing 10. The annular insert portion 19 includes a hole or recess 19d for receiving and securing the hook end 91 of the drive spring 90. In addition, there are features on the annular insert portion 19 that bias the insert portions 12, 19 axially and rotationally to remove free play.

[0083] The cartridge holder 20 is located at the distal side of the housing 10 and can be permanently attached to the housing. The cartridge holder can be a transparent or translucent component that is tubular to receive the cartridge 100. The distal end of the cartridge holder 20 can be provided with a device for attaching a needle arrangement. A removable cap (not shown) can be provided to fit over the cartridge holder 20 and can be retained via a clamp feature on the housing 10.

[0084] The piston rod 30 is rotationally constrained to the drive sleeve 40 via a spline interface. When rotating, the piston rod 30 is forced to move axially relative to the drive sleeve 40 through its threaded interface with the insert 12 of the housing 10. The lead screw 30 is an elongated member in which an external thread engages a corresponding thread of the insert 12 of the housing 10. The interface includes at least one longitudinal groove or track and a corresponding protrusion or spline of the driver 40. At its distal end, the lead screw 30 is provided with an interface for clamping an attachment bearing 140.

[0085] The drive sleeve 40 is a hollow member surrounding the lead screw 30 and arranged within the number sleeve 60. It extends from an interface with the coupling plate 120 to contact with the coupling spring 130. The drive sleeve 40 is axially movable relative to the housing 10, the piston rod 30 and the number sleeve 60 in a distal direction against the bias of the coupling spring 130 and in an opposite proximal direction under the bias of the coupling spring 130.

[0086] The splined tooth interface 18 with the insert 12 prevents rotation of the drive sleeve 40 during dose setting. This interface includes a ring of radially extending external teeth 41 at the distal end of the drive sleeve 40 and corresponding radially extending internal teeth 18 of the housing component 10 (insert 12). When the button 70 is pressed (Figure 3b), these drive sleeves disengage from the housing insert spline teeth, thereby allowing the drive sleeve 40 to rotate relative to the insert and thus relative to the housing 10. The coupling spring 130 biases the drive sleeve 40 to a position in which its teeth 41 engage with the teeth 18 of the insert (Figure 3a). During dialing, another spline tooth that interfaces with the number sleeve 60 is not engaged, but is engaged when the button 70 is pressed, thereby preventing relative rotation between the drive sleeve 40 and the number sleeve 60 during dispensing. In a preferred embodiment, this interface includes inwardly directed splines on a flange on the inner surface of the number sleeve 60 and a radially extending external spline ring of the drive sleeve 40. These corresponding splines are located on the number sleeve 60 and the drive sleeve 40 respectively, so that axial movement of the drive sleeve 40 relative to the (axially fixed) number sleeve 60 engages or disengages the splines, thereby rotationally coupling or decoupling the drive sleeve 40 and number sleeve 60.

[0087] Another interface of the drive sleeve 40 includes a ratchet tooth ring at the proximal end face of the drive sleeve 40 and a corresponding ratchet tooth ring on the coupling plate 120 .

[0088] The driver 40 has a threaded section, thereby providing a helical track for the nut 50. In addition, a last dose abutment or stop is provided, which may be the end of the thread or track, or preferably a rotational hard stop for interacting with a corresponding last dose stop of the nut 50, thus limiting the movement of the nut 50 on the driver thread. At least one longitudinal spline of the driver 40 engages with a corresponding track of the lead screw 30.

[0089] The last dose nut 50 is located between the number sleeve 60 and the drive sleeve 40. It is rotationally constrained to the number sleeve 60 via a spline interface. It moves along a helical path relative to the drive sleeve 40 via a threaded interface conveniently established by means of a helical track when relative rotation occurs between the number sleeve 60 and the drive sleeve 40, which for the presently described mechanism is only during dialing or setting, where dose dialing refers to a dose setting operation. As an alternative, the nut 50 may be splined to the driver 40 and threaded to the number sleeve 60. A last dose stop is provided on the nut 50, engaging a stop of the drive sleeve cartridge 40 when the set dose corresponds to the amount of dispensable medicament or drug remaining in the cartridge 100.

[0090] The dose indicator or number sleeve 60 is a tubular element. During dose setting (via the dose selector 80) and dose correction and during dose dispensing by the torsion spring 90, the number sleeve 60 rotates. The number sleeve 60 together with the metering element 110 defines a zero position or zero dose position ("rest") and a maximum dose position.

[0091] For manufacturing reasons, the number sleeve 60 of the embodiment shown in the figure includes a number sleeve lower part 60a, which is rigidly fixed to the number sleeve upper part 60b during assembly to form the number sleeve 60. The number sleeve lower part 60a and the number sleeve upper part 60b are separate components, which are only used to simplify the molding and assembly of the number sleeve 60. As an alternative, the number sleeve 60 can be a single component. The number sleeve 60 is constrained to the housing 10 by snap-fit ​​engagement to allow rotation but not translation. The number sleeve 60 includes an annular recess or groove near its distal end, which engages the corresponding bead edge on the inner surface of the housing 10. The number sleeve lower part 60a is marked with a series of numbers, which are visible through the metering element 110 and the openings 11a, 11b in the housing 10 to represent the dialed dose of the medicament.

[0092] Further, the number sleeve lower portion 60a has a portion with external threads that engage the metering element 110. End stops are provided at opposite ends of the threads to limit relative movement with respect to the metering element 110.

[0093] A coupling feature in the form of a spline ring is provided on the number sleeve upper part 60b pointing inwardly for engagement with the splines of the button 70 during dose setting and dose correction. A snap arm is provided on the outer surface of the number sleeve 60, which interacts with the drive sleeve 40 and the metering member 110 for generating a feedback signal. In addition, the number sleeve lower part 60a is rotationally constrained to the nut 50 and the coupling plate 120 via a spline interface including at least one longitudinal spline. Further, the number sleeve lower part 60a includes an interface for attaching a torsion spring 90.

[0094] The button 70 forming the proximal end of the device is permanently splined to the dose selector 80. The central rod extends distally from the proximal actuation surface of the button 70. The rod is provided with a flange, which carries a spline for engaging with the spline of the number sleeve upper part 60b. Therefore, when the button 70 is not pressed, the rod is also splined to the number sleeve upper part 60b via the spline, but when the button 70 is pressed, this spline interface is disconnected. The button 70 has a discontinuous annular skirt with splines. When the button 70 is pressed, the splines on the button 70 engage with the splines on the housing 10, thereby preventing the button 70 (and the dose selector 80) from rotating during dispensing. When the button 70 is released, these splines are disengaged, thereby allowing the dose to be dialed. Further, a ratchet tooth ring is provided on the inner side of the button flange for interacting with the coupling plate 120.

[0095] The dose selector 80 is axially constrained to the housing 10. It is rotationally constrained to the button 70 via a spline interface. This spline interface (which includes a groove that interacts with a spline feature formed by the annular skirt of the button 70) remains engaged regardless of the axial position of the dose button 70. The dose selector 80 or dose dial grip is a sleeve-like component with a serrated outer skirt.

[0096] The torsion spring 90 is attached at its distal end by a hook 91 to the insert 12 and thus to the housing 10, and at the other end to the number sleeve 60. The torsion spring 90 is located inside the number sleeve 60 and surrounds the distal portion of the drive sleeve 40. The torsion spring 90 is pre-wound when assembled so that when the mechanism is in the zero unit dial, it applies a torque to the number sleeve 60. The rotational action of the dose selector 80 for setting a dose rotates the number sleeve 60 relative to the housing 10 and further energizes the torsion spring 90.

[0097] The cartridge 100 is received in the cartridge holder 20. The cartridge 100 may be a glass ampoule with a removable rubber stopper at its proximal end. The distal end of the cartridge 100 is provided with a pierceable rubber seal which is held in place by a curled annular metal band. In the embodiment depicted in the figure, the cartridge 100 is a standard 1.5 ml cartridge. The device is designed to be disposable because the cartridge 100 cannot be replaced by a user or health care professional. However, a reusable variant of the device may be provided by making the cartridge holder 20 removable and allowing the back winding of the lead screw 30 and the resetting of the nut 50.

[0098] The metering element 110 is constrained to prevent rotation but is allowed to translate relative to the housing 10 via a spline interface. The metering element 110 has a helical feature on its inner surface that engages with a helical thread cutout in the number sleeve 60, such that rotation of the number sleeve 60 results in axial translation of the metering element 110. This helical feature on the metering element 110 also forms a stop abutment against the end of the helical cutout in the number sleeve 60, limiting the minimum and maximum doses that can be set.

[0099] The metering element 110 has a generally plate-like or strip-like component with a central aperture or window and two flanges extending on either side of the aperture. The flanges are preferably opaque and thus shield or cover the number sleeve 60, while the aperture or window allows viewing of a portion of the lower portion 60a of the number sleeve. Further, the metering element 110 has a cam and a recess that interact with the clicker arm of the number sleeve 60 at the end of dose dispensing.

[0100] The coupling plate 120 is an annular component. The coupling plate 120 is splined to the number sleeve 60 via a spline. It is also coupled to the drive sleeve 40 via a ratchet interface. The ratchet provides a detent position corresponding to each dosage unit between the number sleeve 60 and the drive sleeve 40, and engages different bevel angles during clockwise and counterclockwise relative rotation. The clicker arm is provided on the coupling plate 120 for interacting with the ratchet feature of the button 70.

[0101] The coupling spring 130 is a compression spring. The axial position of the drive sleeve 40, the coupling plate 120 and the button 70 is defined by the action of the coupling spring 130, which exerts a force on the drive sleeve 40 in the proximal direction. This spring force reacts via the drive sleeve 40, the coupling plate 120 and the button 70, and when "at rest", it further reacts to the housing 10 through the dose selector 80. The spring force ensures that the ratchet interface between the drive sleeve 40 and the coupling plate 120 is always engaged. In the "rest" position, it also ensures that the button splines are engaged with the number sleeve splines and the drive sleeve teeth are engaged with the teeth of the housing 10.

[0102] The bearing 140 is axially constrained to the piston rod 30 and acts on the bung within the liquid medicament cartridge. It is axially clamped to the lead screw 30 but is free to rotate.

[0103] 1 and 3a, the number sleeve 60 is positioned with the metering element 110 against its zero dose base and the button 70 is not depressed. The dose marking "0" on the number sleeve 60 is visible through the window 11b of the housing 10 and the metering element 110, respectively.

[0104] A torsion spring 90 (which has a plurality of pre-wound turns applied to it during assembly of the device) applies torque to the number sleeve 60 and is prevented from rotating by the zero dose base.

[0105] The user selects a variable dose of the liquid medicament by rotating the dose selector 80 clockwise, which produces the same rotation in the number sleeve 60. The rotation of the number sleeve 60 causes the torsion spring 90 to be charged, thereby increasing the energy stored therein. As the number sleeve 60 rotates, the metering element 110 translates axially due to its threaded engagement, thereby showing the value or size of the dialed dose, which can be an integer multiple (e.g., 1 IU or 5 IU) of the unit dose increment or the minimum settable dose of the device. For example, a dose of up to 80 IU can be set. The metering element 110 has a flange on either side of the window area, which covers the numbers printed on the number sleeve 60 adjacent to the dialed dose to ensure that only the set dose numbers are visible to the user.

[0106] A particular feature of this embodiment is the inclusion of a visual feedback feature in addition to the typical discrete dose number display on devices of this type. The distal end of the metering element 110 creates a sliding scale that passes through a small window 11a in the housing 10. Alternatively, the sliding scale may be formed using a separate component that engages with a number sleeve 60 on a different helical track.

[0107] When the user sets the dose, the metering element 110 translates axially, and the distance moved is proportional to the set dose amount. This feature provides clear feedback to the user about the approximate size of the set dose. The dispensing speed of the automatic syringe mechanism can be higher than that of the manual syringe device, so the digital dose display may not be read during dispensing. The meter feature provides feedback to the user about the progress of the dispensing during dispensing without having to read the dose numbers themselves. For example, the metering display can be formed by an opaque element on the metering element 110, thereby revealing the contrasting colored components below. Alternatively, the revealable element can be printed with rough dose numbers or other indices to provide more precise resolution. In addition, the metering display simulates the action of the syringe during dose setting and dispensing.

[0108] As the spline teeth of the drive sleeve engage with the teeth of the housing 10, the drive sleeve 40 is prevented from rotating when the set dose and number sleeve 60 is rotated. Therefore, relative rotation between the coupling plate 120 and the drive sleeve 40 must occur via the ratchet interface.

[0109] The user torque required to rotate the dose selector 80 is the sum of the torque required to wind the torsion spring 90 and the torque required to service the ratchet interface. The coupling spring 130 is designed to provide an axial force to the ratchet interface and bias the coupling plate 120 onto the drive sleeve 40. This axial load acts to maintain the coupling plate 120 in engagement with the ratchet teeth of the drive sleeve 40. The torque required to service the ratchet in the dose setting direction is a function of the axial load applied by the coupling spring 130, the clockwise bevel of the ratchet teeth, the coefficient of friction between the mating surfaces, and the average radius of the ratchet interface.

[0110] When the user rotates the dosage selector 80 enough to increment the mechanism by one increment, the number sleeve 60 rotates one ratchet tooth relative to the drive sleeve 40. At this point, the ratchet teeth reengage to the next detent position. An audible click is produced by the reengagement of the ratchet, and tactile feedback is given by the change in torque input required.

[0111] Relative rotation of the number sleeve 60 and the drive sleeve 40 is permitted. This relative rotation also causes the last dose nut / tracking member 50 to travel along its threaded path towards its last dose abutment on the drive sleeve 40.

[0112] In the absence of user torque applied to the dosage selector 80, the number sleeve 60 is now prevented from rotating back under the torque applied by the torsion spring 90 only by the ratchet interface between the coupling plate 120 and the drive sleeve 40. The torque required to service the ratchet in the counterclockwise direction is a function of the axial load applied by the coupling spring 130, the counterclockwise bevel angle of the ratchet, the coefficient of friction between the mating surfaces, and the average radius of the ratchet feature. The torque required to service the ratchet must be greater than the torque applied by the torsion spring 90 to the number sleeve 60 (and therefore the coupling plate 120). Therefore, the ratchet bevel angle is increased in the counterclockwise direction to ensure this condition, while ensuring that the toggle torque is as low as possible.

[0113] The user can now choose to increase the selected dose by continuing to rotate the dose selector 80 in a clockwise direction. The process of ratcheting the interface between the number sleeve 60 and the drive sleeve 40 is repeated for each dose increment. Additional energy is stored in the torsion spring 90 for each dose increment, and audible and tactile feedback is provided for each increment dialed by the reengagement of the ratchet teeth. The torque required to rotate the dose selector 80 increases as the torque required to wind the torsion spring 90 increases. Therefore, the torque required to ratchet in the counterclockwise direction must be greater than the torque applied by the torsion spring 90 to the number sleeve 60 when the maximum dose has been reached.

[0114] If the user continues to increase the selected dose until the maximum dose limit is reached, the number sleeve 60 engages with its maximum dose base on the maximum dose base of the metering element 110. This prevents further rotation of the number sleeve 60, the coupling plate 120 and the dose selector 80.

[0115] Depending on how many increments the mechanism has delivered, during selection of a dose, the last dose nut 50 may have its last dose abutment in contact with a stop surface (e.g., an angled surface) of the drive sleeve 40. The abutment prevents further relative rotation between the number sleeve 60 and the drive sleeve 40 and thus limits the dose that can be selected. The position of the last dose nut 50 is determined by the total number of relative rotations between the number sleeve 60 and the drive sleeve 40 that have occurred each time the user sets a dose.

[0116] With the mechanism in a state where a dose has been selected, the user is able to deselect or decrement any number of increments from this dose. Deselection of a dose is achieved by the user rotating the dose selector 80 counterclockwise. The torque applied by the user to the dose selector 80, when combined with the torque applied by the torsion spring 90, is sufficient to overhaul the ratchet interface between the coupling plate 120 and the drive sleeve 40 in a counterclockwise direction. When the ratchet is overhauled, a counterclockwise rotation occurs in the number sleeve 60 (via the coupling plate 120), which returns the number sleeve 60 towards the zero dose position and releases the torsion spring 90. The relative rotation between the number sleeve 60 and the drive sleeve 40 causes the last dose nut 50 to return along its helical path away from the last dose base.

[0117] With the mechanism in a state where a dose has been selected, the user can activate the mechanism to start delivery of the dose. Delivery of the dose is initiated by the user depressing the button 70 axially in the distal direction (Fig. 3b).

[0118] When the button 70 is depressed, the splines between the button 70 and the number sleeve 60 disengage, thereby rotationally disconnecting the button 70 and the dose selector 80 from the delivery mechanism (i.e., from the number sleeve 60, the metering element 110 and the torsion spring 90). The splines on the button 70 engage with the splines on the housing 10, thereby preventing the button 70 (and thus the dose selector 80) from rotating during dispensing. Since the button 70 is stationary during dispensing, it can be used in a dispensing clicker mechanism. The stop feature in the housing 10 limits the axial travel of the button 70 and reacts to any axial abuse loads applied by the user, thereby reducing the risk of damage to internal components.

[0119] The coupling plate 120 and the drive sleeve 40 and button 70 travel axially. This engages the spline tooth interface between the drive sleeve 40 and the number sleeve 60, thereby preventing relative rotation between the drive sleeve 40 and the number sleeve 60 during dispensing. The spline tooth interface 18, 41 between the drive sleeve 40 and the housing insert 12 is disengaged, so the drive sleeve 40 can now rotate and is driven by the torsion spring 90 via the number sleeve 60 and the coupling plate 120.

[0120] Rotation of the drive sleeve 40 causes the piston rod 30 to rotate due to its splined engagement and then advance due to its threaded engagement with the housing 10. Rotation of the number sleeve 60 also causes the metering element 110 to axially traverse back to its zero position, whereby the zero dose stop stops the mechanism.

[0121] Tactile feedback during dose dispensing is provided via a compliant cantilevered clicker arm integrated into the coupling plate 120. This arm radially interfaces with a ratchet feature on the inner surface of the button 70, whereby the ratchet tooth spacing corresponds to the rotation of the number sleeve 60 required for a single incremental dispensing. During dispensing, as the number sleeve 60 rotates and the button 70 is rotationally coupled to the housing 10, the ratchet feature engages the clicker arm to produce an audible click as each dose increment is delivered.

[0122] As the user continues to depress the button 70, delivery of the dose continues via the mechanical interaction described above. If the user releases the button 70, the coupling spring 130 returns the drive sleeve 40 to its "rest" or initial position (together with the coupling plate 120 and button 70), engaging the splines between the drive sleeve 40 and the housing 10, preventing further rotation and stopping dose delivery.

[0123] During dose delivery, the drive sleeve 40 and the number sleeve 60 rotate together so that no relative movement occurs in the last dose nut 50. Hence, the last dose nut 50 travels axially relative to the drive sleeve 40 only during dialing.

[0124] Once dose delivery has ceased, the user may release the button 70 by returning the number sleeve 60 to the zero dose station, which will re-engage the spline teeth between the drive sleeve 40 and the housing 10. The mechanism now returns to the "rest" condition.

[0125] Rather than providing multiple "clicks" during dispensing, additional audible feedback in the form of a "click" is provided at the end of dose dispensing to inform the user that the device has returned to its zero position through the interaction of the snap arm on the number sleeve 60 with the ramp on the drive sleeve 40 and the cam and recess on the metering element 110. This embodiment allows feedback to be generated only at the end of dose delivery, and no feedback is generated if the device is dialed back or away from the zero position.

[0126] The drug delivery device discussed above is configured to deselect or reduce any number of dose increments of a previously set dose by means of an increasing mechanism. The mechanism disclosed above utilizes the servicing of a ratchet to reduce the set dose. This ratchet must be able to withstand a continuously increasing torque applied by a spring, which increases with the size of the set dose (i.e., the number of unit increments that the dose comprises). Therefore, servicing the ratchet may require a large force and / or generate a large noise.

[0127] When referring to an "axial", "angular", "circumferential", or "radial" direction in the present disclosure, the axis designating these directions may be the axis of the corresponding component or member, the axis of the housing (particularly the main longitudinal axis of the housing), the axis of rotation about which the component or member rotates, and / or the axis of the drug delivery device (particularly the main longitudinal axis of the device). The axis may be oriented so that it extends through the proximal and / or distal end of the device. In particular, the proximal direction or the distal direction may be parallel to and / or along the axis.

[0128] The housing is conveniently stationary so that if a part or member is rotated and / or moved axially, it always moves relative to the housing. The respective parts or members may be arranged so that they rotate about a common axis of rotation (e.g. the longitudinal axis of the housing). The axis of rotation may extend through the respective member.

[0129] The drug delivery device discussed above includes a nut 50 as a tracking member, which is displaced along a guide track (helical thread) on a driver or drive sleeve 40 when a dose is set by rotating a number sleeve or dose indicator 60. Therefore, references to the nut above and / or below can be regarded as references to the tracking member. References to the driver or drive sleeve 40 can be regarded as references to a general drive member. References to a dose setting member can be regarded as referring to a dose selector 80. The driver 40 preferably directly engages the piston rod. The button 70 can serve as or correspond to an activation member, which is used to start a dose dispensing operation when a dose setting member has been used to set a dose, as has been described previously. When the user moves the activation member, the mechanism can be switched from a dose setting operation mode for a dose setting operation to a dose dispensing operation mode for a dose delivery operation. By pressing the activation member, the activation member moves from a first or initial position to a second or dispensing position, which positions are axially, preferably only axially offset from each other. When the activation member is released, the activation member moves back (e.g., in the proximal direction) toward the initial position again. When the activation member or button is released, it is moved back to the initial position by a spring, such as a coupling spring 130. In the mechanism discussed above, the release of the activation member interrupts the dose dispensing process. Therefore, the activation member must be pressed during the entire dose dispensing process. However, the presently disclosed concept also works with devices in which a dose is dispensed once the activation member 70 has been pressed, without the option of interrupting the dose delivery operation, for example by releasing the activation member 70.

[0130] The distance of the tracking member 50 from the axial end position relative to the housing and / or the distance as seen along the guide track or spiral track of the driver 40 is characteristic of the amount of drug remaining in the cartridge 100, as has been discussed previously. The cartridge 100 comprises a cartridge body (e.g., made of glass) and a stopper, which seals the proximal end of the cartridge body and dispenses liquid drug from the interior of the cartridge body through an opening in the cartridge or cartridge body when moving toward the distal end of the cartridge body, in particular when fluid communication is established between the interior and the exterior of the cartridge, for example, by a needle unit comprising a needle. In the absence of a needle, the distal end or dispensing end of the cartridge may be sealed by a septum. The septum may be pierced by a needle of a needle unit, which may be attached to the distal end of a cartridge holder 20. The cartridge holder 20 may be designed to receive a cartridge. The composition of the cartridge is not explicitly shown in the accompanying drawings as is the needle unit.

[0131] In the embodiment already discussed further above, the tracking member 50 (i.e. the last dose nut) has been arranged close to the interface where the driver 40 transfers force to the piston rod 30. In particular, the tracking member is guided by a guide track on the driver 40. During dose setting, the tracking member 50 is driven by the number sleeve 60.

[0132] In the following, further embodiments of operating and / or arranging a tracking member within a drug delivery device and / or an assembly for a drug delivery device are described. In contrast to the arrangement of the tracking member in Figures 1 to 5b, the tracking member will be arranged closer to the dose setting member, as seen along the force transmission path from the dose setting member 80 to the tracking member 50. Therefore, the following embodiments provide (end of content) a tracking mechanism that can be used as an alternative to the mechanism described in conjunction with Figures 1 to 5b.

[0133] Figures 6a and 6b illustrate exemplary embodiments of a drug delivery device, in particular a drug delivery device including a tracking mechanism. Figure 6a shows an exploded view of the components or members of the drug delivery device involved in operating the mechanism. Figure 6b shows the components or members when assembled. Since the main functions of the device correspond to the functions discussed further above in conjunction with Figures 1 to 5b, the following discussion focuses on the differences, but the features discussed above are of course also applicable to the present embodiment.

[0134] The drug delivery device includes a dose setting member 80. The drug delivery device also includes a tracking member 50. The drug delivery device also includes a housing 10. The housing 10 may be an outer housing of a drug delivery device as discussed further above. In particular, FIGS. 6a and 6b show a proximal region of the housing and / or drug delivery device. The tracking member 50 is configured as a nut. The tracking member 50 is arranged to engage a guide track 150 (e.g., a helical thread). The guide track 150 may be disposed on the housing 10. The guide track 150 is disposed in a proximal region of the housing 10 (e.g., adjacent to a proximal opening 152 of the housing 10). The guide track 150 may be offset proximally from a window in the housing 10 (e.g., from window 11b). The guide track 150 in the depicted embodiment is disposed on an outer surface of the housing 10. The tracking member 50 includes a tracking member interaction feature 154 (e.g., a protrusion, a thread, or a portion of a thread) that is arranged to engage the guide track 150. The tracking member 50 is rotationally locked to the dose setting member 80. For this purpose, the tracking member 50 and the dose setting member 80 comprise corresponding spline features 156 and 158. A plurality of corresponding spline features 156 and 158 may be provided to be arranged circumferentially around the respective members. The spline features are configured to prevent relative rotational movement between the dose setting member and the tracking member (conveniently in two opposite rotational directions). However, relative axial movement between the tracking member 50 and the dose setting member 80 is allowed. One or more protrusions as spline features 156 may be provided on the outer surface of the tracking member 50. In particular, the protrusions may protrude in the radial direction. The corresponding spline features 158 may comprise notches or slots in the dose setting member 80. In other words, in this embodiment, the tracking member 50 engages the housing 10 and the dose setting member 80. As in the previously described embodiments, the dose setting member 80 is axially fastened to the housing 10, but is rotatable relative to the housing. The axial fixation of the dose setting member to the housing is not explicitly shown in the drawings, but may be implemented, for example, by circumferentially extending notches in the housing and corresponding protrusions on the dose setting member engaging said notches. The activation member 70 may be partially received in the dose setting member.The activation member 70 may close the proximal opening of the dose setting member 80.

[0135] The housing 10, which is offset distally from the guide track 150, may include a protrusion or flange 160 pointing radially outward. The protrusion may provide a distal stop for the tracking member 50. Alternatively or additionally, a rotational end stop may be provided on the housing 10 (e.g. in the region of the flange 160). The rotational end stop may provide an angular surface that the tracking member 50 may have to prevent further rotation. The proximal end stop of the tracking member 50 may be provided by a protrusion or flange 162 provided in the dose setting member 80.

[0136] The axial extension of the portion of the housing 10 received inside the dose setting member 80 may have an axial extension greater than or equal to the axial extension of the guide track 150. The section of the dose setting member axially overlapping with the housing may be greater than or equal to 0.5 cm and / or less than or equal to 2.0 cm.

[0137] The spline feature 158 may be provided in a distal portion of the dose setting member 80 (e.g., provided distally from the protrusion 162). In a proximal portion of the dose setting member, one or more further spline features 164 may be arranged. The button or activation member 70 (see FIG. 6 b ) is rotationally locked to the dose setting member 80, but is axially movable relative to the dose setting member, as already discussed above. For this purpose, the spline feature 164 may engage a corresponding spline feature 166 in the activation member 70. By way of example only, the spline feature 164 is a radially oriented indentation and the spline feature 166 is a radially oriented protrusion.

[0138] The assembly further comprises one or more locking features 168 and 170, which are configured to cooperate to rotationally lock the activation member 70 relative to the housing 10, in particular when a dose delivery operation or a dose dispensing operation has been initiated by pushing the activation member 70 distally. The respective locking features can be designed as teeth, which can be axially oriented and / or circumferentially arranged. When engaged, the teeth mesh and prevent relative rotational movement in either rotational direction. When the activation member is rotationally locked, so is the dose setting member 80. It is advantageous to establish a rotational lock before releasing the rotational coupling between the driver 40 and the number sleeve or dose indicator 60 for a dose delivery operation. Then, the risk of accidentally moving the dose setting member 80 and thus the tracking member 50 is reduced.

[0139] FIG. 6 b shows, in its left part, an arrangement in a dose setting state based on a schematic cross-sectional view, wherein the dose setting member 80 can be rotated relative to the housing 10 in order to set a dose of a specific size to be delivered by the device. In the depicted situation, the tracking member 50 is in its initial position relative to the guide track 150 (e.g., in a proximal initial position). That is, a dose setting operation and a dose delivery operation have not yet been performed. If the dose setting member 80 is rotated, the tracking member 50 moves axially relative to the dose setting member 80 and the housing 10 towards its axial end position (e.g., distally towards the flange 160) due to the spline and threaded engagement with the dose setting member and the housing. If the set dose is corrected (e.g., reduced by rotating the dose member in the opposite direction to during dose setting), the tracking member is shifted back towards its initial position. The number sleeve 60 can, for example, cooperate with an end stop on the housing to provide a zero dose base and thus prevent the dose setting member from rotating in a direction that would reduce the set dose if the dose has not yet been set. This has been discussed above in conjunction with the embodiments shown in FIGS. 1 to 5 b.

[0140] In case a dose delivery operation is initiated by pressing the button or activation member 70 distally (i.e. to the left in FIG. 6 b ), the locking features 168 and 170 are brought into mechanical cooperation. Preferably, the locking features 168 and 170 are already in cooperation before releasing the rotational coupling between the number sleeve and the dose setting member, before releasing the rotational lock of the driver 40 to the housing 10 and / or before mechanically interacting the driver 40 and the number sleeve 60 to transfer the drive spring force from the number sleeve 60 to the driver 40. In this way, it can be ensured that the dose setting member 80 is not rotated in a direction opposite to the dose setting direction when a dose delivery operation has been initiated. This ensures an accurate position of the tracking member 50 relative to the housing 10 and the guide track 150 and in particular relative to its axial end position. The coupling coupling acting between the dose setting member and the number sleeve for transferring the rotation from the dose setting member to the number sleeve can be established by a coupling feature on the activation member engaging the number sleeve.

[0141] The right-hand part of Fig. 6b shows the situation when the tracking member 50 has reached an axial end position (e.g. a distal position). In this case, it is no longer possible to further increase the currently set dose, because the rotation is blocked by the tracking member 150 abutting the end stop (e.g. a flange 160) or a rotation end stop provided on the housing. Thus, the tracking member blocks a rotation of the dose setting member that would be required to increase the set dose.

[0142] During dose setting, when the dose setting member 80 rotates, the rotation is transferred to the tracking member 50 due to the rotation lock between the tracking member and the dose setting member. In other words, the rotation of the dose setting member is converted into an axial displacement of the tracking member (due to the guide track 150 guiding the movement of the tracking member). The movement of the tracking member is directly driven by the dose setting member. During the dose delivery operation, the activation member 70 is locked in a rotational manner relative to the housing 10 due to the engagement of the locking features 168 and 170.

[0143] It should be noted that during setting, the tracking member 50 does not need to be advanced distally. It should be readily appreciated that the same functionality can also be achieved with a tracking member that advances proximally towards the end position. Furthermore, as will be readily appreciated, the guide track can also be provided on the inner surface of the dose setting member 70, rather than on the outer surface of the housing. In this case, the spline feature can be provided on the housing 10 (e.g. on its outer surface). This arrangement will result in the same kinematics of the dose setting member 80 driving the axial displacement of the tracking member when the tracking member is rotationally locked to the housing and threadedly engaged with the dose setting member.

[0144] In the embodiments discussed above, the tracking member 50 directly interacts with the dose setting member 80, which forms a section or part of the outer surface of the drug delivery device. Further, the tracking member 50 directly interacts with the housing 10. Specifically, the tracking member 50 is arranged between the dose setting member 80 and the housing 10. The distal portion of the dose setting member 80 may be designed to receive the tracking member 50.

[0145] Figures 7a and 7b illustrate another exemplary embodiment of a drug delivery device, in particular including a tracking mechanism. Similarly, Figure 7a shows an exploded view of the parts or components of the drug delivery device, and Figure 7b shows the components in an assembled state based on a schematic cross-sectional view. The parts or components involved in the mechanism are substantially the same as those discussed in the previous embodiments. Therefore, the following description will focus on the differences. Of course, the features disclosed in conjunction with the previous embodiments can also be used in conjunction with this embodiment.

[0146] One difference from the previous embodiment is that the tracking member is arranged inside the proximal region of the housing 10. The spline feature 158 is provided in this region of the housing. The proximal region of the housing 10 can be wider than the region distally adjacent to the proximal region (e.g., the region between the proximal region of the housing and the window 11b). Between the more distal region and the proximal region, an inwardly directed step is provided on the outer surface of the housing. This helps to provide an interior space with a larger diameter that can receive the tracking member 50. However, it should be noted that other shapes are also possible.

[0147] The spline feature 158 is provided to cooperate with the spline feature 156 of the tracking member 50. The guide track 150 is provided on the activation member 70 (e.g., on its distal end and / or the shaft portion). The guide track 150 can be arranged distally relative to the locking feature 170 of the activation member 70. Therefore, in this embodiment, the tracking member engages with the activation member 70 and the housing 10. The tracking member engages with the outward-facing surface of the activation member and the inward-facing surface of the housing.

[0148] As depicted in FIG. 7 b , the tracking member 50 is arranged between the activation member and the housing 10. In an initial position, for example when the cartridge is still full, the tracking member 50 may be arranged to be offset distally relative to a proximal position, which may be defined by a proximal stop 162 (as is apparent from the situation when the tracking member is in its end position in the right-hand part of FIG. 7 b ) or by a rotational end stop. The proximal position may be defined by an axial stop or a rotational stop or by a combination of axial and rotational end stops. The rotational end stop may be formed by the end of a guide track 150 or by another end stop 162 that is separate from the track (e.g., provided on the activation member 70). The initial position of the tracking member is illustrated in the left-hand part of FIG. 7 b . In the representation of FIG. 7 b , the axial locking of the dose setting member 80 relative to the housing 10 is illustrated by a protrusion that protrudes radially inwards from the dose setting member, thereby engaging a circumferential recess or notch in the housing 10. Of course, this axial locking may also be implemented in a different way.

[0149] During dose setting, the activation member 70 rotates due to the rotational lock between the activation member 70 and the dose setting member 80. This rotation drives the movement of the tracking member. For example, the activation member rotates relative to the tracking member 50, and as a result, the tracking member is displaced relative to the thread and axially relative to the housing due to the spline connection with the housing, which constrains the relative rotation between the tracking member and the housing. In the depicted embodiment, the tracking member 50 travels proximally towards the end position during dose setting. Likewise, as in the previous embodiments, it is also conceivable to have the tracking member 50 travel distally towards its end position during dose setting. During dose delivery, the dose setting member 80 is rotationally locked relative to the housing due to the engagement of the locking features 168 and 170, as has been discussed previously. Conveniently, the rotational lock is established before releasing the corresponding coupling engagement between the activation member 70 and the number sleeve 60 and / or between the driver 40 and the housing 10. Likewise, the coupling features that rotationally lock the activation member to the number sleeve are not explicitly shown. When the activation member 70 is moved distally, so is the tracking member 50, since the guide track is arranged on the activation member 70. The guide track 150 is conveniently a self-locking thread. This is different from the embodiment in Figures 6a and 6b, in which the movement of the activation member 70 has no effect on the position of the tracking member relative to the housing.

[0150] In the end position shown in the right part of FIG. 7 b , the dose setting member 80 cannot be rotated further to increase the dose because the activation member 70 is prevented from rotating by the tracking member 50 abutting the end stop 162, which is rotationally locked to the housing. Since the activation member is rotationally locked to the dose setting member, this prevents the dose setting member from rotating in a direction that would increase the set dose. Thus, this embodiment also provides an end-of-content tracking mechanism or final dose stop mechanism, just like the previously discussed embodiments.

[0151] As already mentioned for the previously described embodiments, in this embodiment, a reverse configuration is also possible, wherein the tracking member is threadedly engaged to the housing and splined to the activation member. In most cases, this is less preferred than the configuration depicted in the drawings, as the manufacture of an internal threaded surface is generally more difficult than an external or outer threaded surface, especially when molding the component.

[0152] It should be noted that at least some concepts (e.g. concepts discussed in connection with FIGS. 7a and 7b ) are also applicable to dose setting members that are not axially locked to the housing (e.g. dose setting members that are axially displaced relative to the housing during a dose setting operation and / or during a dose delivery operation). Conversely, the concepts may also be used for dose setting members that are displaced relative to the housing, in particular dose setting members that are displaced a distance that is independent of or not proportional to the size of the currently set dose and that is preferably constant for each dose delivery and / or dose setting operation.

[0153] 8a to 8d schematically illustrate another embodiment of a drug delivery device, in particular including a tracking mechanism. FIG8a illustrates a portion of a drug delivery device, including a proximal portion thereof, the proximal portion having a dose setting member 80, a housing 10 and an activation member 70. In this embodiment, the dose setting member 80 serves as the tracking member 50. FIG8a shows an initial state of the device, wherein the tracking member 50 is in its initial axial position. In this initial state, a dose setting operation and a dose delivery operation have not yet been performed. The dose setting member 80 is again splined or rotationally locked to the activation member 70. As can be seen from the schematic cross-sectional view of FIG8c, the tracking member 50 / dose setting member 80 has a spline feature 172 (e.g. a protrusion) which engages a corresponding spline feature 174 (e.g. a slot) in the activation member 70.

[0154] As opposed to the embodiments already discussed previously, the dose setting member is not axially locked relative to the housing 10. Instead, the dose setting member is threadedly coupled to the housing 10. Thus, the dose setting member is displaced relative to the housing, for example in the proximal direction or away from the distal end, by a distance that is characteristic of or proportional to the size of the set dose. In the depicted embodiment, a thread 176 (e.g., a helical thread) is provided on the dose setting member (in particular, its inner surface), which interacts with an interaction feature 178 on the housing (in particular, its outer surface). Of course, the positions of the thread and the interaction feature 178 may also be reversed, and / or both the dose setting member and the housing may be provided with threads that engage with each other. The spline feature 172 spans the housing 10 and in particular its proximal end so as to engage the activation member 70. The activation member 70 is arranged within the housing, as seen in a top view, arranged to the proximal end. The dose setting member 80 is arranged outside the housing, and in particular, the housing may be partially received in the dose setting member 80.

[0155] Since the dose setting member 80 is threadedly coupled to the housing 10, the axial position of the dose setting member relative to the housing changes as the set dose increases. Preferably, during a dose setting operation, the dose setting member moves to a proximal direction relative to the housing (i.e., away from the distal end of the housing). By doing so, the distance between the proximal end faces 180 of the activation member 70 is reduced because the activation member 70 is axially stationary during dose setting. In the initial stage depicted in FIG. 8 a , the distance by which the activation member 70 protrudes from the proximal end face of the dose setting member is greater than the total axial displacement distance of the tracking member 50 from its initial position to its axial tracking member end position (i.e., when the assembly has performed a dose delivery operation until the assembly is configured to deliver a maximum total dose (which is the sum of all deliverable doses)).

[0156] In the end position of the tracking member 50 or the dose setting member 80, further rotation that would increase the size of the currently set dose is prevented. This position is depicted in FIG. 8b. As is apparent, when the dose setting member has reached its axial end position, the activation member 70 still protrudes proximally from the dose setting member 80. Preferably, this distance is still sufficient to allow movement of the activation number 70 in the distal direction relative to the dose setting member required to initiate a dose delivery operation, such as to release the coupling mechanism (e.g., by rotationally decoupling the number sleeve 60 and the dose setting member 80, rotationally coupling the driver 40 to the number sleeve 60 for a delivery operation and / or rotationally unlocking the driver 40 from the housing 10).

[0157] In order to ensure or prevent this, once a dose delivery operation has been triggered by pressing the activation member 70, rotation of the dose setting member 80 is conveniently restricted during the dose delivery operation and / or while the activation member is being pressed. This achieves that the position of the tracking member 50 relative to the axial end position of the tracking member does not change or cannot easily change during dose delivery and, therefore, the position of the tracking member always reflects the cumulative dose that has been dispensed from the device before starting the next setting operation.

[0158] In the present embodiment, this can be achieved via a force transfer mechanism (e.g. a ratchet) which still allows the activation member to be moved axially to the position required to initiate the dose delivery operation. The force transfer mechanism can transfer a portion of the distally directed axial force provided by the user to press the activation member 70 onto the interface between the thread 176 and the interface feature 178. This is shown in a very schematic manner in FIG. 8d. As depicted, an axially directed locking feature is provided which establishes a rotational lock for the dose setting member 80 or tracking member 50 relative to the housing 10 when the thread 176 and the interaction feature 178 are axially moved toward each other. The dose setting member 80 / tracking member 50 is then no longer rotatable relative to the housing 10 in either rotational direction.

[0159] All tracking mechanisms discussed in connection with FIGS. 6a to 8d guide the tracking member on a surface with a relatively large diameter. Furthermore, the end stops which prevent further rotation once the tracking member has reached its axial end position can be arranged at a relatively large diameter. Therefore, the forces acting on the end stops are relatively small. Furthermore, the loads transmitted to the tracking member can be reacted quickly by the housing and do not need to be guided through more sensitive components of the dose setting and drive mechanism. Therefore, the proposed tracking mechanism does have decisive advantages.

[0160] The terms "drug" or "medicament" are used synonymously herein and describe a pharmaceutical preparation containing one or more active pharmaceutical ingredients or a pharmaceutically acceptable salt or solvate thereof and optionally a pharmaceutically acceptable carrier. In the broadest sense, an active pharmaceutical ingredient ("API") is a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or medicament is used to treat, cure, prevent, or diagnose disease or to otherwise enhance physical or mental health. A drug or medicament may be used for a limited duration, or periodically for a chronic disorder.

[0161] As described below, a drug or medicament may include at least one API or a combination thereof in various types of formulations for treating one or more diseases. Examples of APIs may include small molecules (having a molecular weight of 500 Da or less); polypeptides, peptides, and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes); carbohydrates and polysaccharides; and nucleic acids, i.e., double-stranded or single-stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids may be incorporated into a molecular delivery system (e.g., a vector, a plasmid, or a liposome). Mixtures of one or more drugs are also contemplated.

[0162] The drug or medicament can be contained in a primary package or "drug container" suitable for use with a drug delivery device. The drug container can be, for example, a cartridge, a syringe, a reservoir or other solid or flexible vessel, which is configured to provide a suitable chamber for storing (e.g., short-term or long-term storage) one or more drugs. For example, in some cases, the chamber can be designed to store the drug for at least one day (e.g., 1 day to at least 30 days). In some cases, the chamber can be designed to store the drug for about 1 month to about 2 years. Storage can occur at room temperature (e.g., about 20 ° C) or refrigerated temperature (e.g., from about -4 ° C to about 4 ° C). In some cases, the drug container can be or can include a dual-chamber cartridge, which is configured to store two or more components (e.g., API and diluent, or two different drugs) of a drug preparation to be administered separately, one of which is stored in each chamber. In such cases, the two chambers of the dual-chamber cartridge can be configured to allow mixing between two or more components before and / or during distribution to the human or animal body. For example, the two chambers can be configured so that they are in fluid communication with each other (e.g., through a conduit between the two chambers) and allow the user to mix the two components if necessary before dispensing. Alternatively or in addition, the two chambers can be configured to allow mixing when the components are dispensed into the human or animal body.

[0163] The medicine or medicament contained in the drug delivery device as described herein can be used to treat and / or prevent many different types of medical disorders. The example of obstacle includes, for example, diabetes or complications associated with diabetes (such as diabetic retinopathy), thromboembolic disorders (such as deep vein or pulmonary thromboembolism). Another example of obstacle is acute coronary syndrome (ACS), angina pectoris, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis. The example of API and medicine is those as described in the following manual: such as Rote Liste 2014 (for example, but not limited to, main group (main group) 12 (antidiabetic drugs) or 86 (tumor drugs)) and Merck Index, the 15th edition.

[0164] Examples of APIs for treating and / or preventing type 1 or type 2 diabetes or complications associated with type 1 or type 2 diabetes include insulin (e.g., human insulin, or human insulin analogs or derivatives); glucagon-like peptide (GLP-1), GLP-1 analogs or GLP-1 receptor agonists, or analogs or derivatives thereof; dipeptidyl peptidase-4 (DPP4) inhibitors, or pharmaceutically acceptable salts or solvates thereof; or any mixture thereof. As used herein, the terms "analogs" and "derivatives" refer to polypeptides having a molecular structure that can be formally derived from the structure of a naturally occurring peptide (e.g., the structure of human insulin) by deleting and / or exchanging at least one amino acid residue present in a naturally occurring peptide and / or by adding at least one amino acid residue. The added and / or exchanged amino acid residues can be codable amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogs are also referred to as "insulin receptor ligands." In particular, the term "derivative" refers to a polypeptide having a molecular structure that is formally derived from the structure of a naturally occurring peptide (e.g., the structure of human insulin), wherein one or more organic substituents (e.g., fatty acids) are bound to one or more amino acids. Optionally, one or more amino acids present in the naturally occurring peptide may have been deleted and / or replaced by other amino acids (including non-encodable amino acids), or amino acids (including non-encodable amino acids) have been added to the naturally occurring peptide.

[0165] Examples of insulin analogs are Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); human insulin in which the proline at position B28 is replaced by Asp, Lys, Leu, Val or Ala and in which the Lys at position B29 may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0166] Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (insulin detemir, ); B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoylLysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-γ-glutamyl)-des(B30) human insulin, B29-N-ω-carboxypentadecanoyl-γ-L-glutamyl-des(B30) human insulin (insulindegludec, ); B29-N-(N-lithocholyl-γ-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0167] Examples of GLP-1, GLP-1 analogs and GLP-1 receptor agonists are e.g. lixisenatide Exendin-4 Liraglutide (a 39-amino acid peptide produced by the salivary glands of the Gila monster) Semaglutide, Taspoglutide, Albiglutide Dulaglutide rExendin-4, CJC-1134-PC, PB-1023, TTP-054, Langlenatide / HM-11260C, CM-3, GLP-1 Eligen, ORMD-0901, NN-9924, NN-9926, NN-9927, Nodexen, Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR709, ZP-2929, ZP-3022, TT-401, BHM-034, MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, Exenatide-XTEN, and Glucagon-Xten.

[0168] Examples of oligonucleotides are e.g. Mipomersen sodium It is a cholesterol-reducing antisense therapeutic used to treat familial hypercholesterolemia.

[0169] Examples of DPP4 inhibitors are Vildagliptin, Sitagliptin, Denagliptin, Saxagliptin, Berberine.

[0170] Examples of hormones include pituitary hormones or hypothalamic hormones or regulatory activity peptides and their antagonists, such as gonadotropins (follicle-stimulating hormone, luteinizing hormone, chorionic gonadotropin, tocopherol), somatropine (growth hormone), desmopressin, terlipressin, gonadorelin, triptorelin, leuprorelin, buserelin, nafarelin and goserelin.

[0171] Examples of polysaccharides include glucosaminoglycanes, hyaluronic acid, heparin, low molecular weight heparin or ultra low molecular weight heparin or derivatives thereof, or sulfated polysaccharides (e.g., polysulfated forms of the above polysaccharides), and / or pharmaceutically acceptable salts thereof. An example of a pharmaceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan GF 20 It is a sodium hyaluronate.

[0172] As used herein, the term "antibody" refers to an immunoglobulin molecule or an antigen binding portion thereof. Embodiments of the antigen binding portion of an immunoglobulin molecule include F (ab) and F (ab') 2 fragments, which retain the ability to bind to an antigen. The antibody can be a polyclonal antibody, a monoclonal antibody, a recombinant antibody, a chimeric antibody, a deimmunized antibody or a humanized antibody, a fully human antibody, a non-human (e.g., mouse) antibody or a single-chain antibody. In some embodiments, the antibody has effector functions and can fix complement. In some embodiments, the antibody has reduced or no ability to bind to Fc receptors. For example, the antibody can be an isotype or subtype, an antibody fragment or a mutant, and the antibody does not support binding to Fc receptors, for example, it has a mutagenic or missing Fc receptor binding region. The term antibody also includes antigen binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTI) and / or dual variable region antibody-like binding proteins with a cross-binding region orientation (CODV).

[0173] The term "fragment" or "antibody fragment" refers to a polypeptide (e.g., antibody heavy chain and / or light chain polypeptide) derived from an antibody polypeptide molecule, which does not include a full-length antibody polypeptide, but still includes at least a portion of a full-length antibody polypeptide capable of binding an antigen. Antibody fragments may include cleavage portions of full-length antibody polypeptides, although the term is not limited to such cleavage fragments. Antibody fragments that can be used in the present invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments (e.g., bispecific, trispecific, tetraspecific and multispecific antibodies (e.g., double-chain antibodies, three-chain antibodies, four-chain antibodies)), monovalent or multivalent antibody fragments (e.g., bivalent, trivalent, tetravalent and multivalent antibodies), mini antibodies, chelated recombinant antibodies, three antibodies or double antibodies, intracellular antibodies, nano antibodies, small modular immunopharmaceuticals (SMIP), binding domain immunoglobulin fusion proteins, camelized antibodies and antibodies containing VHH. Other examples of antigen-binding antibody fragments are known in the art.

[0174] The term "complementarity determining region" or "CDR" refers to short polypeptide sequences within the variable region of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term "framework region" refers to amino acid sequences within the variable region of both heavy and light chain polypeptides that are not CDR sequences and are primarily responsible for maintaining the correct positioning of the CDR sequences to allow antigen binding. Although the framework region itself is generally not directly involved in antigen binding, as is known in the art, certain residues within the framework region of certain antibodies may be directly involved in antigen binding or may affect the ability of one or more amino acids in the CDR to interact with the antigen.

[0175] Examples of antibodies are anti-PCSK-9 mAb (eg, Alirocumab), anti-IL-6 mAb (eg, Sarilumab), and anti-IL-4 mAb (eg, Dupilumab).

[0176] Pharmaceutically acceptable salts of any API described herein are also contemplated for use as drugs or medicaments in drug delivery devices.Pharmacologically acceptable salts are, for example, acid addition salts and basic salts.

[0177] Those skilled in the art will appreciate that modifications (additions and / or removals) may be made to the various components of the API, formulations, apparatus, methods, systems and embodiments described herein without departing from the full scope and spirit of the invention, and that the invention encompasses such modifications and any and all equivalents thereof.

[0178] The scope of protection is not limited to the examples given above. The present invention is embodied in each novel feature and each combination of features, in particular including each combination of any features described in the claims, even if this feature or this combination of features is not explicitly described in the claims or embodiments.

[0179] Reference numerals

[0180] 10 Shell (housing)

[0181] 11a, 11b windows

[0182] 12 Inserts

[0183] 13 Sidewall

[0184] 14 Tube

[0185] 15 Arm

[0186] 16 bottom wall

[0187] 17 Thread

[0188] 18 spline teeth

[0189] 19 Ring Part 2

[0190] 19a Spline teeth

[0191] 19b Arm (spline)

[0192] 19c Arm (Snap Clamp)

[0193] 19d Opening

[0194] 20 Cartridge holder

[0195] 30 Piston rod (lead screw)

[0196] 40 driving sleeve (driving member)

[0197] 41 spline teeth

[0198] 50 Nut

[0199] 60 Digital sleeve (dose indication component)

[0200] 60a Number sleeve lower part

[0201] 60b Number sleeve upper

[0202] 70 Buttons

[0203] 80 Dose selector / dose setting member

[0204] 90 Torsion Spring

[0205] 91 Hook

[0206] 100 Cartridges

[0207] 110 Metering element

[0208] 120 Coupling plate

[0209] 130 Coupling spring

[0210] 140 Bearings

[0211] 150 Guide Track

[0212] 152 Opening

[0213] 154 Interaction characteristics

[0214] 156 Spline Features

[0215] 158 Spline Features

[0216] 160 bulge

[0217] 162 Flange

[0218] 164 Spline Features

[0219] 166 Spline Features

[0220] 168 Locking feature

[0221] 170 Locking feature

[0222] 172 Spline Features

[0223] 174 Spline Features

[0224] 176 Thread

[0225] 178 Interaction characteristics

[0226] 180 Proximal surface

Claims

1. A component for a drug delivery device, the component comprising: - a housing (10) having a proximal end and a distal end, - a dose setting member (80) rotatable relative to the housing for a dose setting operation in order to set a dose of drug to be delivered, wherein The assembly further comprises a tracking member (50), wherein The tracking member is operably coupled or coupleable to the dose setting member, wherein the assembly comprises a further member (60), wherein the dose setting member (80) is operably coupled or coupleable to the further member so as to transfer force from the dose setting member to the further member via a setting coupling mechanism, the setting coupling mechanism being configured to couple the further member to the dose setting member during the dose setting operation, the setting coupling mechanism comprising a coupling force transfer interface, in the dose setting operation force is transferred from the dose setting member to the further member via the coupling force transfer interface, wherein the further member is coupled to the dose setting member during the dose setting operation The device is rotationally locked to the dose setting member during a setting operation, and wherein force is transferred from the dose setting member to the tracking member via a tracking member force transfer interface (156 / 158, 150 / 154, 176 / 178), wherein the tracking member force transfer interface (156 / 158, 150 / 154, 176 / 178) is arranged closer to an outer surface of the dose setting member than a coupling force transfer interface of the setting coupling mechanism, and during the dose setting operation, force is transferred from the dose setting member to the further member via the coupling force transfer interface as seen along a force transfer path from the outer surface to the respective force transfer interface, and The assembly further comprises a guide track (150), wherein the guide track is configured to form a guide interface to guide and / or drive the movement of the tracking member, wherein the assembly is configured such that the tracking member is displaced towards an axial tracking member end position during the dose setting operation, wherein a distance by which the tracking member is displaced towards the axial tracking member end position depends on the size of the set dose.

2. The assembly according to claim 1, wherein The tracking member force transfer interface (156 / 158, 150 / 154, 176 / 178) is disposed proximally relative to the coupling force transfer interface.

3. The assembly according to claim 1 or 2, in, The relative position between the tracking member (50) and the axial tracking member end position is constant during a dose delivery operation which is performed after the dose setting operation.

4. The assembly according to claim 1 or 2, in, The tracking member (50) is arranged relative to the housing (10) such that the tracking member axially overlaps the dose setting member (80).

5. The assembly according to claim 1 or 2, in, The tracking member (50) is arranged between an outer surface of the housing (10) and an inner surface of the dose setting member (80).

6. The assembly according to claim 1 or 2, in, The dose setting member (80) is axially locked to the housing (10), but is rotatable relative to the housing for the dose setting operation.

7. The assembly according to claim 1 or 2, in, The dose setting member (80) is engaged to the housing (10) via the guide track (150).

8. The assembly according to claim 1 or 2, in, The assembly comprises an activation member (70) operable to perform a dose delivery operation for delivering a previously set dose, wherein the activation member is configured to be touched by a user and moved from a first position to a second position for the dose delivery operation, wherein the assembly is configured such that during movement of the activation member from the first position to the second position: i) releasing the setting coupling mechanism such that the dose setting member (80) is decoupled from the further member (60), and / or ii) rotationally locking the dose setting member (80) relative to the housing (10).

9. The assembly according to claim 8, in, The assembly is configured such that the dose setting member (80) is rotationally locked relative to the housing (10) before the setting coupling mechanism is released.

10. The assembly according to claim 1 or 2, wherein: The tracking member (50) is engaged to the dose setting member (80).

11. The assembly according to claim 8, wherein The tracking member (50) is engaged to the activation member (70).

12. The assembly of claim 8, wherein: The boot interface is established in - between the tracking member (50) and the housing (10), - between the tracking member (50) and the activating member (70), or - between the tracking member (50) and the dose setting member (80).

13. The assembly according to claim 1 or 2, wherein: The tracking member (50) is arranged in a proximal region of the housing (10).

14. The assembly according to claim 1 or 2, wherein: When the tracking member reaches the tracking member end position, the dose setting member is prevented from further rotation in a direction that would increase the size of the set dose.

15. The assembly according to claim 1 or 2, wherein: When the tracking member reaches the tracking member end position, a reduction in the set dose is allowed.

16. The assembly according to claim 1 or 2, wherein: The assembly further includes an energy storage member configured to store energy for use in a dose delivery operation.

17. The assembly of claim 16, wherein: The energy storage member is a spring.

18. A drug delivery device comprising an assembly according to any one of claims 1 to 17 and a reservoir (100) containing a drug and / or a reservoir holder (20) for holding the reservoir containing a drug.

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