Cartridge assembly and fixing member

Abstract

The present disclosure relates to a cartridge assembly provided with a fixing member, the fixing member (100) being configured for fastening to a cartridge (10), the cartridge (10) being configured for insertion into a housing component (30) of a drug delivery device (1), the housing component (30) having a side wall (32) limiting a cartridge receiving space (33), the cartridge receiving space (33) extending in a longitudinal direction (z), the fixing member (100) comprising: - a fastening portion (110) for fastening to a neck (16) of the cartridge (10); - a fixing structure (120) comprising a first fixing element (121) configured to engage with a counter fixing structure (60) of the housing component (30); and - an alignment portion (130) configured to align with a counter alignment structure (34) provided on or in the side wall (32) of the cartridge holder (31).

Description

[Technical field]

[0001] The present disclosure relates to a cartridge assembly, in particular to a cartridge assembly for a drug delivery device such as an injection device and / or a pen injector. The present disclosure further relates to a fixing member for use in the cartridge assembly, a drug delivery device, and a method of assembling the cartridge assembly. [Background technology]

[0002] Drug delivery devices for setting and dispensing single or multiple doses of liquid medicaments are well known per se in the art. Generally, such devices have a purpose substantially similar to that of a conventional syringe.

[0003] Drug delivery devices such as pen-type injectors must meet several user-specific requirements. For example, in the case of patients suffering from chronic diseases such as diabetes, the patient may be physically debilitated and may also have poor eyesight. Therefore, a suitable drug delivery device, especially for home drug treatment, needs to be robust in construction and should be easy to use. Furthermore, the operation and general handling of the device and its components should be clear and easy to understand. Such an injection device should allow the setting and subsequent ejection of drug doses of varying sizes. Moreover, the dose setting and dose ejection procedures must be easy to perform and unambiguous.

[0004] Patients suffering from certain diseases need to inject a quantity of medication via a pen-type injection syringe or infuse through a pump. For reusable injection or delivery devices, the patient may need to load or replace a cartridge. Reusable injection devices typically include a multi-component housing. For example, the housing may comprise a proximal housing component, such as a body, and a distal housing component, such as a cartridge holder, removably connectable to the body. When a medication container, such as a cartridge, is emptied of medication, the cartridge holder may be disconnected from the body of the injection device and the empty cartridge may be removed and replaced with a new cartridge.

[0005] Another concern arises from cartridges, since they are essentially manufactured in standard sizes and to meet certain recognized local and international standards. As a result, such cartridges are usually supplied in standard size cartridges (e.g., 3 ml cartridges). Thus, there may be a variety of cartridges supplied by several different suppliers, containing different medications, but fitting into a single drug delivery device. As just one example, a first cartridge containing a first medication from a first supplier may fit into a drug delivery device provided by a second supplier. Thus, a user may be able to load the wrong cartridge or medication into a drug delivery device and then dispense said medication (e.g., rapid-acting insulin or basal insulin) without realizing that the medical delivery device is perhaps not designed or intended to be used with such a cartridge.

[0006] Thus, there is an increasing demand from users, health care providers, caregivers, regulators, and medical device suppliers to reduce the potential risk that a user will load the wrong drug type into a drug delivery device. It is also desirable to reduce the risk of dispensing the wrong drug (or the wrong concentration of a drug) from such drug delivery devices.

[0007] Some approaches to avoid unintended cross-use of cartridges with unintended drug delivery devices include mechanically fixing the cartridge to a housing component of the drug delivery device, such as a cartridge holder, which may then be removably or non-removably connectable to a dosing mechanism of such drug delivery device.

[0008] A cartridge configured for insertion into a cartridge holder of a drug delivery device typically comprises a tubular-shaped body merging into a radially narrowed neck, which in turn merges into a distally located and radially widened head. The head is typically covered by a septum retainer made of a fairly flexible material, for example an aluminum cap. The septum retainer is configured to fasten a pierceable septum at the distal end of the head. In some approaches for fixing the cartridge to the cartridge holder, the cartridge holder comprises a radially inwardly protruding structure, which is configured to engage the radially narrowed neck and / or grip under the beaded cap of the cartridge. In such approaches, upon insertion of the cartridge into the cartridge holder, the septum retainer may collide with the protruding structure of the cartridge holder, which in turn may lead to mechanical and / or visual defects in the area of ​​the septum retainer of the cartridge. Summary of the Invention [Problem to be solved by the invention]

[0009] It is therefore desirable to provide an improved cartridge assembly that provides reliable and durable fixation of the cartridge to the cartridge holder and avoids damage or imperfections of the cartridge upon insertion into the cartridge holder. [Means for solving the problem]

[0010] In one embodiment, a fixing member for fastening to a cartridge is provided. The cartridge is configured for insertion into a housing component of a drug delivery device, e.g., an injection device, such as a pen-type injector. The housing component of the drug delivery device comprises a sidewall that limits a cartridge-receiving space. The cartridge-receiving space extends in a longitudinal direction, e.g., shown as the longitudinal axis direction (z). The fixing member comprises a fastening portion for fastening to a neck of the cartridge. The fixing member further comprises a fixing structure. The fixing structure comprises at least a first fixing element configured to engage with a counter fixing structure of the housing component. The fixing member further comprises an alignment portion configured to align with a counter alignment structure provided on or in the sidewall of the housing component.

[0011] Typically, the fastener provides for fastening of the fixing member to the neck of the cartridge. The fastener can be fixed to the cartridge via the fastener. The fastener typically comprises a mechanical fastening feature that engages with the neck of the cartridge. In some examples, the fastener comprises a fastening clip for clip fastening to the neck of the cartridge.

[0012] The securing structure is configured to engage a complementary counter securing structure on the housing component via which the securing member can be secured, fastened and / or retained to the housing component. In some examples, the securing member serves to secure the securing member to the housing at least longitudinally.

[0013] Typically, the counter fixing structure is provided on a side wall that defines the cartridge receiving space. The fixing structure may be provided on an outwardly facing portion of the fixing member, and may face the inward side of the side wall of the housing component when the fixing member fastened to the cartridge is accommodated in the cartridge receiving space together with the cartridge.

[0014] The alignment feature is configured to align with a complementary counter alignment feature provided on or in the side wall, typically on the inside of the side wall that defines the cartridge receiving space.

[0015] In some examples, the alignment portion is configured to assist and / or orient the fixing member in at least one precise or dedicated orientation with respect to the housing component or housing portion and / or with respect to the counter-fixing structure. In this way, the alignment portion assists in accurately aligning or accurately orienting the fixing member with respect to the side wall and thus with respect to the counter-fixing structure as provided on or in the side wall. In this way, by accurately aligning the alignment portion of the fixing member with the counter-aligning structure of the side wall, the fixing structure of the fixing member can be properly aligned or oriented with respect to the counter-fixing structure as provided on or in the housing component, for example with respect to the side wall of the housing component. As a result, when accurately aligned, the fixing member attached or fastened to the cartridge can be inserted longitudinally with the cartridge into the cartridge receiving space until the cartridge and / or the fixing member reach a final assembly position inside the cartridge receiving space.

[0016] When the final assembly position is reached, the fastening portion of the fixing member is precisely aligned with the counter-fixing structure due to the mutual engagement of the alignment portion with the counter-alignment structure, which, when the final assembly configuration is reached, engages the counter-fixing structure and serves to fix, at least in the longitudinal direction, the fixing member, and thus the cartridge connected thereto, to the housing component.

[0017] In some examples, the fixing member can be attached to a neck of the cartridge, which is provided at or near the distal end of the cartridge. The counter-fixing structure of the housing component may also be provided at or near the distal end of the housing component and / or at or near the distal end of the cartridge-receiving space. The cartridge provided with the fixing member may have to be inserted into the cartridge-receiving space through an insertion opening, which may be provided at or near the proximal end of the housing component. The precise mechanical engagement of the fixing structure with the counter-fixing structure may require precise alignment and / or precise orientation of the fixing structure relative to the counter-fixing structure as seen in the short direction, e.g. as seen with respect to a rotation axis coinciding with the long direction.

[0018] Thus, a locking structure can only accurately engage with a complementary counter locking structure when it is accurately oriented or aligned with respect to the longitudinally extending axis of rotation.

[0019] In some examples, the counter alignment structure extends along the longitudinal direction. The alignment portion of the fixing member is configured to engage and / or align with the counter alignment structure, which may extend from the proximal end towards the distal end of the cartridge-receiving space. The counter alignment structure may have a rather rectilinear shape and may extend along the longitudinal direction of the side wall that bounds the cartridge-receiving space. As the counter alignment structure is provided on or in the side wall of the cartridge-receiving space, the fixing member can be precisely aligned and oriented with respect to the axis of rotation.

[0020] In some examples, insertion of the locking member into the housing component when fastened to the neck of the cartridge may be possible and only possible with the alignment portion being correctly aligned or correctly oriented with respect to the counter alignment structure. Two, three, or even more acceptable or supported alignment configurations may be provided between the alignment portion of the locking member and the counter alignment structure of the side wall of the housing. All available or possible mutual orientations or alignments of the alignment portion with the counter alignment structure will allow the locking structure to engage the counter locking structure.

[0021] In some instances, any other orientation or alignment of the alignment portion relative to the counter alignment structure, i.e., when the alignment portion is misaligned relative to the counter alignment structure, would not allow the locking structure to engage the counter locking structure of the housing component. These other unsupported alignments may block and / or prevent insertion of the cartridge or locking member into the cartridge-receiving space. Here, it may be of particular benefit for the alignment portion to prevent the cartridge with the locking member from being inserted into the cartridge-receiving space as long as the alignment portion is improperly aligned with respect to the counter alignment structure.

[0022] In this way, the counter alignment structure and the alignment portion provide a kind of mechanical coding between the fixing member and the cartridge receiving space. In a mismatched configuration, where the alignment portion is, for example, misaligned or misoriented with respect to the counter alignment structure, the alignment portion blocks the insertion of the fixing member and the cartridge into the cartridge receiving space, for example, by a proximally located insert opening of a housing component. In an acceptable or supported configuration, where the alignment portion of the fixing member is correctly aligned or oriented with the counter alignment structure, the alignment portion is configured to slide along the counter alignment structure when the fixing member fixed to the cartridge is pushed into the cartridge receiving space into the insert opening until the cartridge and / or the fixing member reach a final assembly position.

[0023] When correctly aligned or oriented as defined by the inter-engagement of the alignment portion with the counter alignment structure, the locking structure of the locking member is configured to precisely engage with a complementary counter locking structure of the housing component, thereby locking the locking member, and thus the cartridge secured or fastened thereto, to the housing component, at least in the longitudinal direction (z). In effect, as the locking structure engaged with the complementary counter locking structure, the locking member, and thus the cartridge connected thereto, can be secured against proximal removal from the cartridge receiving space.

[0024] According to a further example, the locking structure of the locking member is configured to engage with the counter locking structure in the longitudinal direction and lock the cartridge relative to the housing component in the longitudinal direction. The locking structure may be configured or implemented as a form-fit locking structure. It may comprise a snap element that engages with a complementary counter snap element of the counter locking structure. The locking structure and the counter locking structure may be engageable by providing the locking structure against the counter locking structure in the longitudinal distal direction. When the final assembly configuration is reached, complementary stop surfaces of the locking structure and the counter locking structure may engage, thereby preventing movement of the locking structure in the opposite direction and thus in the proximal direction relative to the counter locking structure.

[0025] The locking structure comprises at least one radial protrusion and one radial recess which engages with one of the radial recess and the radial protrusion of the counter-locking structure. The radial protrusion may be provided with a beveled edge to induce radial deformation during approaching or upon reaching the final assembly configuration. In the final assembly configuration, the complementary stop surfaces of the locking structure and the counter-locking structure may engage and abut longitudinally, thereby retaining the locking structure and thus the locking member inside the cartridge receiving space and the cartridge attached to the locking member.

[0026] According to a further example, the alignment portion comprises one of a radial convexity and a radial alignment recess that engages with one of a complementary radial alignment recess and a radial convexity as provided on the inner surface of the sidewall of the housing component. In some examples, the alignment portion of the fixing member comprises a radially outwardly extending convexity that engages with a complementary radial alignment recess as provided on the inner side of the sidewall of the housing component. The radial alignment recess may comprise a longitudinal groove that effectively extends across the entire cartridge receiving space. The radial alignment recess may merge into the insert opening to define at least one or several acceptable alignment or orientation configurations of the fixing member relative to the sidewall of the housing.

[0027] When correctly aligned, the radial protrusion of the alignment portion engages with a complementary radial alignment recess in the side wall of the housing component to allow and support insertion of the fixing member and its attached cartridge into the cartridge-receiving space. To the extent that the radial protrusion is out of alignment with the complementary radial alignment recess, the respective insertion movements into the cartridge-receiving space are effectively blocked. The radial protrusion may then abut against a proximal end surface of the side wall that defines the cartridge-receiving space, thereby preventing insertion of the cartridge and fixing member into the cartridge-receiving space.

[0028] In a further example, the alignment portion of the securing member comprises a radial alignment recess on its outer surface which engages a complementary radial protrusion projecting radially inwardly from an inner surface of the side wall of the housing component In this manner, rotational alignment or orientation for insertion of the securing member and its attached cartridge into the cartridge-receiving recess can likewise be provided.

[0029] In either instance of the alignment portion and the radial protrusion provided on one of the insides of the side walls of the housing component, the alignment portion and the inter-engagement of the radial protrusion with the radial alignment recess on the other one of the insides of the side walls of the housing component, a rotationally preventing or keyed engagement is provided between the fixing member and the cartridge receiving space. In either manner, the counter alignment structure as provided on or in the side wall of the housing component provides a kind of symmetry breaking function, thus defining at least one or some predetermined orientation or alignment of the fixing member relative to the housing component or the cartridge receiving space.

[0030] In other words, the mechanical coding as provided by the alignment portion of the locking member and the complementary counter-alignment structure of the side wall limits the number of possible orientations of the locking member with respect to the cartridge receiving space. Thus, there is only a limited number of configurations in which the locking structure is engageable with the counter-locking structure. Thus, the inter-engagement of the alignment portion of the locking member with the counter-alignment structure on or in the side wall of the housing component provides a two-fold function. Firstly, it prevents rotation of the locking member relative to the housing component when inserting a cartridge into the housing component. Secondly, it provides and allows a guiding function for the locking structure provided on the locking member to purposefully engage with a complementary counter-locking structure on the inside of the housing component that may not be accessible from the outside of the housing component.

[0031] According to a further example, the fastening portion comprises a fastening ring. The fastening ring comprises a first ring portion and a second ring portion. The first ring portion and the second ring portion are separated from each other by a slit opening. To that extent, the fastening ring is an interrupted ring intersected by the slit opening, thus forming a through hole through the fastening ring. Apart from the slit opening, the fastening ring may be annular in shape. The slit opening increases the degree of elasticity of the first ring portion and the second ring portion. The first ring portion and the second ring portion may be somewhat semicircular in shape. That part or section of the first ring portion and the second ring portion facing away from the slit opening may be connected to each other.

[0032] In some examples, the fixing member and / or the ring portion of the fastening portion are integrally formed. It is made from a unitary structure. The fixing member may comprise a unitary body. The unitary body may comprise a plastic component, e.g., an injection molded plastic component. In other examples, the fixing member and / or the fastening ring may comprise a metal component. Also herein, the fastening ring and / or the body of the fixing member may comprise a unitary structure.

[0033] The fastening ring having a first ring portion and a second ring portion is suitable for fastening to a neck of a cartridge. The cartridge typically comprises a tubular barrel extending via a radially narrowing shoulder to a radially narrowed neck. The neck may further extend to a slightly radially widened head. The head is typically provided with a seal, for example a pierceable septum.

[0034] The first and second ring parts, separated from each other by a slit opening, elastically deform relative to each other, thus enabling the clip to fasten onto the neck of the cartridge. The slit opening may be slightly smaller than the diameter of the neck of the cartridge. It may be radially engaged with the neck of the cartridge. By applying a radially inwardly directed pressure on the fastening ring, the first and second ring parts may undergo a slight radially outwardly directed deformation, thereby temporarily increasing the size of the slit opening to receive the neck inside the aperture as formed by the fastening ring. After or when receiving the neck of the cartridge between the first and second ring parts, the first and second ring parts may be allowed to relax towards an initial, e.g., unbiased, state, in which the first and second ring parts tightly receive the neck. In this way, the first and second ring parts engage the neck in a form-fitting manner. Furthermore, the first and second ring parts may even be in a friction fit with the neck of the cartridge. Through the friction fit, the fastening ring, and thus the fastening portion of the fastening member, may be fixed even against rotation relative to the cartridge.

[0035] According to a further example, the fastening ring comprises an intermediate portion interconnecting the first and second ring portions. The first and second ring portions may be directly adjacent or may merge with each other. In that case, the merge section may be indicated as the intermediate portion. The intermediate portion may be structurally reinforced compared to the first and second ring portions, thereby increasing the stability of the fastening portion.

[0036] According to a further example, the alignment portion is provided on an outer surface of the intermediate portion. The alignment portion may be directly connected to the fastening portion. It may comprise a longitudinal extension connected to the fastening portion or a longitudinal extension integrally formed with the fastening portion. Typically, the fastening portion, the fixing structure and the alignment portion are substantially fixed relative to each other. Apart from their inherent elastic deformation capabilities, they are conveniently stationary relative to each other.

[0037] By providing a registration portion on the outer surface of the intermediate portion, the registration portion may break the annular symmetry of the fastening ring. Further, any forces present at the registration portion may be distributed equally to the first and second ring portions protruding from the registration portion in opposite circumferential or tangential directions.

[0038] In a further example, the fixing structure comprises a second fixing element, where the first fixing element is provided on the first ring portion, and the second fixing element is provided on the second ring portion. In some examples, the first fixing element and the second fixing element may be provided at diametrically opposite positions on the fastening ring. In this way, any mechanical force transmitted through the first fixing element and the second fixing element can be transmitted somewhat symmetrically to the fastening ring. A double mechanical fixation can be provided between the fixing structure and a complementary counter fixing structure via the first fixing element and the second fixing element.

[0039] In this way, the stability of the mechanical fastening as provided by the fastening member for holding the cartridge inside the cartridge receiving space can be improved. Furthermore, by having a first fastening element and a second fastening element on either side of the fastening ring, a redundant mechanical fastening of the fastening member, and thus of the cartridge, to the cartridge receiving space and ultimately to a housing component of the drug delivery device can be provided.

[0040] In some examples, the first and / or second fixation elements include radially outwardly extending protrusions that engage complementary recesses as provided by the counter fixation structure. In this manner, the counter fixation structure can eliminate radially inwardly protruding features or structures that may otherwise compromise the integrity of the cartridge or its septum retainer.

[0041] According to a further example, the alignment portion of the fixing member comprises a longitudinal extension protruding longitudinally from the fastening ring, via which a fairly accurate longitudinal alignment of the alignment portion with a counter alignment structure such as is provided on or in the side wall of the housing component can be provided, whereby a fairly inclined free-sliding movement of the alignment portion can be provided, since the alignment portion slides along a complementary counter alignment structure of the side wall of the housing component during a longitudinally sliding insertion movement of the cartridge into the cartridge-receiving space.

[0042] Additionally, the longitudinal extension may further function as a handle or gripping feature to facilitate mechanical handling of the fastening member, for example to attach the fastening member to the cartridge. Additionally, the longitudinal extension of the alignment portion may protrude only from one longitudinal side or face of the fastening structure, thereby defining a single way of how to attach the fastening ring or fastener to the cartridge. In general, the fastening ring may be attachable to the neck of the cartridge in two different orientations. The longitudinal extension, as provided by the alignment portion, provides a longitudinal symmetry breaking function, thus showing the user only one correct way of how to fasten and place the fastening member on the cartridge.

[0043] Typically, the alignment portion must extend proximally from the fastening portion when the fixing member is correctly assembled to the cartridge. In other words, the fixing element must project from the fastening portion towards the proximal end of the cartridge. Thus, when correctly attached or assembled to the cartridge, the fixing element must point or extend away from the distal outlet end of the cartridge. If the user should unintentionally attach the fastening portion to the neck of the cartridge in the wrong way, the alignment portion, in particular its longitudinal extension, may project longitudinally from the distal end of the cartridge, thus preventing full insertion of the cartridge into the cartridge receiving space. To that extent, the longitudinal extension of the alignment portion also provides a double function. First of all, it serves to correctly align and correctly orient the fixing structure of the fixing member with respect to the counter fixing structure of the housing component. Secondly, the longitudinal extension provides a kind of symmetry breaking function, in particular when the fixing structure comprises a fastening ring. The symmetry breaking function defines the only correct way of how the fixing member is attached to the cartridge.

[0044] According to a further example, the first fixation element comprises a snap element having an abutment surface facing in a proximal longitudinal direction that abuts a complementary abutment surface of the housing component. The first fixation element further comprises a beveled edge facing in a distal longitudinal direction. Thus, the abutment surface and the beveled edge or side face in opposite longitudinal directions.

[0045] This configuration of the first locking element is specifically dedicated to a distally directed insertion movement of the locking member and cartridge into the cartridge receiving space, e.g., through or via a proximally located insert opening of the housing component, the beveled edge of the locking element serving to induce elastic deformation of the locking element and / or of a complementary shaped counter locking structure of the housing component.

[0046] When the final assembled configuration is reached, the abutment surface of the fixation element abuts longitudinally with a complementary abutment surface of the housing component, which typically faces distally to engage the proximally facing abutment surface of the first fixation element. In this manner, the fixation structure can be secured against proximal removal of the fixation member from the cartridge receiving space. As the fastening portion of the fixation member remains permanently engaged with the neck, the entire cartridge is effectively prevented from sliding proximally out of the cartridge receiving space.

[0047] In a further example, the second fastening element also comprises a snap element, which may be shaped somewhat similarly to the snap element as described above with respect to the first fastening element, thus providing a double snap fastening acting in the longitudinal direction when the cartridge provided with the fastening member reaches the final assembled position.

[0048] In another aspect, a cartridge assembly for a drug delivery device is provided. The cartridge assembly comprises a cartridge. The cartridge comprises a tubular shaped barrel that contains a medicament. The cartridge, in particular its barrel, comprises a neck and is characterized, for example, by a small diameter compared to the tubular shape of the main part of the barrel. The cartridge assembly further comprises a housing component of the drug delivery device. The housing component is typically implemented as a cartridge holder. The housing component comprises a sidewall that defines a cartridge receiving surface extending in the longitudinal direction. Typically, the housing is also somewhat tubular in shape. The housing component further comprises a counter fixing structure and a counter alignment structure. The counter fixing structure and / or the counter alignment structure are provided on or in a sidewall of the housing component.

[0049] The cartridge assembly further comprises a locking member as described above, the locking member being fastenable to the neck of the cartridge, the locking member being configured to engage with the counter locking structure when fastened to the neck of the cartridge, and further configured to align with the counter alignment structure prior to or during insertion of the cartridge into the cartridge receiving space.

[0050] Typically, during placement or assembly of the cartridge in the cartridge-receiving space, a registration portion of the fixing member attached to the cartridge is aligned with a counter registration structure such as provided on or in a side wall of the housing component. Correct alignment of the registration portion with the counter registration structure enables and supports longitudinal sliding insertion of the cartridge and the fixing member into the cartridge-receiving surface. Once in or when the final assembly position is reached, e.g. when or when the cartridge-receiving space is substantially occupied by the cartridge, the locking structure of the fixing member engages with a counter locking structure of the housing component, thereby locking and / or retaining the cartridge and the fixing member inside the cartridge-receiving space.

[0051] Since cartridge assemblies typically utilize such securing members, all of the features, advantages, and benefits associated with such securing members likewise apply to cartridge assemblies including such securing members.

[0052] In some examples, the fixing member is attachable or fixable to a neck of the cartridge adjacent or near the longitudinal distal end of the cartridge. The cartridge, with the fixing member attached to the cartridge, is insertable in the longitudinal distal direction through the insertion opening of the housing component into the cartridge receiving space. Typically, the insertion opening of the housing component for receiving the cartridge and the fixing member may be provided at or near the proximal end of the housing component. Since the fixing member is located at or near the distal end of the cartridge, the counter fixing structure of the housing component that mechanically engages the fixing structure of the fixing member is also located at or near the distal end of the cartridge receiving space. Since the fixing structure is provided at one or several dedicated circumferential positions with respect to the tubular shape of the cartridge, the complementary shaped counter fixing structure of the housing component that engages with the fixing structure is also provided only at distinct dedicated circumferential or tangential positions.

[0053] To provide a suitable interengagement between a locking structure as provided on the locking member and a counter locking structure as provided, for example, on the inside of a side wall of the housing component, an alignment portion is provided on the locking member, which is configured to engage and / or slide along a complementary counter alignment structure on or in the side wall of the housing component. The counter alignment structure may be adjacent to the proximal end face of the side wall of the housing component or may extend towards and to the proximal end face of the side wall of the housing component. The counter alignment structure may enforce or require a precise alignment or orientation of the locking member. In other cases, distal insertion of the locking member and cartridge into the cartridge receiving space may be blocked. When the alignment portion of the locking member is precisely aligned with the counter alignment structure as provided on or in the side wall of the housing component, longitudinal sliding movement of the locking member and the cartridge attached thereto into the cartridge receiving space is supported.

[0054] Here, the alignment portion and the counter alignment structure are a kind of keyed engagement that prevents rotation of the fixing member relative to the side wall of the housing component, while at the same time supporting longitudinal non-rotational sliding movement of the fixing member relative to the side wall of the housing component, where during insertion of the cartridge and the fixing member attached to the cartridge into the cartridge-receiving space, the engagement of the alignment portion with the counter alignment structure provides a kind of longitudinal non-rotational sliding guide for the fixing structure engaging with the counter fixing structure inside the housing component.

[0055] According to a further example, the housing component comprises or forms a cartridge holder with a proximal end configured for attachment to the body of the drug delivery device. The proximal end of the cartridge holder further comprises an insert opening dimensioned to receive the cartridge and the fixing member attached to the cartridge in only one or several orientations of the cartridge and the fixing member relative to the cartridge holder. Here, the orientation of the cartridge or the fixing member relative to the cartridge holder means its rotational position with respect to the longitudinal direction of the housing component as the axis of rotation. Furthermore, the longitudinal axis of symmetry of the tubular cartridge may also serve as a virtual axis of rotation about which the cartridge and the fixing member attached to the cartridge can rotate in order to obtain a proper alignment with a counter-alignment structure such as provided on the side wall of the cartridge holder.

[0056] The fastening member is usually provided as a separate part. It may be mechanically fastened to the cartridge neck simply by a kind of mechanical clipping operation. Existing cartridges can be easily retrofitted with such a fastening member. The fastening member comprises a fastening part and a fastening structure, which is configured to engage with a complementary shaped counter fastening structure as provided on or in the housing component and thus on or in the cartridge holder. Since it may be difficult to ascertain the position of the counter fastening structure from outside the cartridge holder, the mutual alignment and guidance as provided by the alignment part engaged with the counter alignment structure provides a respective longitudinal guidance for the fastening structure such that it mechanically engages with the counter fastening structure when the cartridge and the fastening member attached to the cartridge reach their final assembled configuration inside the cartridge receiving space.

[0057] According to a further example, the counter alignment structure of the cartridge assembly comprises a longitudinally extending alignment recess on an inner surface of the side wall of the cartridge holder, the longitudinally extending alignment recess being complementary to a radially outwardly protruding alignment portion of the fixing member, in this manner providing a keyed engagement between the counter alignment structure of the side wall and the alignment portion of the fixing member.

[0058] In another example, it may be a counter alignment structure comprising a radially inwardly projecting alignment portion that engages a complementary longitudinally extending alignment recess on the outer surface of the securing member. In this manner, similarly anti-rotational longitudinal guidance can be provided between the side wall of the housing component and the securing member attached to the cartridge.

[0059] According to a further example, the counter-locking structure, as provided in or on the side wall, is configured to engage with a first locking element of the locking member when the cartridge provided with the locking member reaches a final assembly position inside the cartridge-receiving space. Typically, the counter-locking structure and the first locking element serve to engage longitudinally or axially to axially or longitudinally hold the locking member, and thus the cartridge attached to the locking member, inside the cartridge-receiving space. When engaged, the locking structure and the counter-locking structure prevent removal of the locking member, and thus the cartridge, from the cartridge-receiving space in a proximal direction.

[0060] The counter-fixing structure and the fixing structure may engage in a snap-like manner, where at least one of the fixing structure and the counter-fixing structure may comprise a protrusion that engages with a complementary recess in the other one of the counter-fixing structure and the fixing structure.

[0061] In some examples, the counter-fixing structure of the cartridge holder may be free of any radially inwardly protruding fixing elements that may otherwise impair the integrity or functionality of the dispensing end of the cartridge upon insertion of the cartridge into the cartridge-receiving space, where it may be only the fixing structure of the fixing member comprising at least one or more radially outwardly extending fixing elements that engage with one or more radial recesses as provided on the inside of the side wall of the cartridge holder.

[0062] According to a further example, the first locking element is longitudinally aligned with the first counter-locking element upon insertion of the cartridge and locking member into the cartridge-receiving space through alignment of the locking member's alignment portion with the counter-alignment structure of the side wall. The keyed engagement of the alignment portion with the counter-alignment structure serves to guide and longitudinally align the locking structure with the counter-locking structure. The mutual engagement of the alignment portion with the counter-alignment structure serves to prevent rotation of the locking member relative to the housing component during insertion into the cartridge-receiving space. Thus, when correctly aligned, the locking structure and the counter-locking structure can be engaged by a distal sliding movement of the locking member relative to the housing component or cartridge holder.

[0063] According to a further example, the cartridge assembly may be implemented as a disposable cartridge assembly. Once the locking structure engages with the counter locking structure, the mutual engagement cannot be defeated, for example, except by destruction of the housing component. In another example, the cartridge assembly is implemented as a reusable cartridge assembly. Here, the counter locking structure may allow and support a clear release from the locking structure. For example, this may be provided, for example, from outside the housing component, using a dedicated tool designed in particular to modify the configuration or shape of the counter locking structure. Here, in some examples, the counter locking structure may comprise a recess in the side wall of the housing component, which recess may be implemented as a through-hole, thereby allowing for biasing a tool of appropriate size into and / or through the recess to remove the first locking element from engagement from the counter locking structure. The same may also apply to configurations in which the locking structure comprises a first locking element and a second locking element.

[0064] It may then be possible to remove the cartridge and the fixing member attached to the cartridge in a proximal direction from the cartridge-receiving space. The empty cartridge may then be replaced with a new cartridge. The fixing member may remain attached to the cartridge or may be removed from the empty cartridge. It may be reattached to the new cartridge. The fixing member and the new cartridge may then be reinserted into the cartridge-receiving space of the housing component, which may for example be implemented as a cartridge holder.

[0065] According to another aspect, the present disclosure also relates to a method of assembling a cartridge assembly of a drug delivery device, for example an injection device such as a pen-type injector. The method of assembling a cartridge assembly may be implemented or performed by utilizing a cartridge assembly as described above. The method comprises, for example, fastening a fixing member as described above to a neck of a cartridge filled with a medicament. The method further comprises aligning an alignment portion of the fixing member with a counter-alignment structure as provided on or in a side wall of a cartridge holder of the drug delivery device.

[0066] The method then comprises the step of inserting the cartridge and the fixing member attached to the cartridge into the cartridge receiving space of the cartridge holder. Typically, inserting the cartridge comprises a purely longitudinal sliding movement of the cartridge into the cartridge receiving space, the mutual engagement of the alignment parts with the counter alignment structure serving to prevent rotation of the cartridge or the fixing member relative to the cartridge receiving space. Finally, in a further step, the fixing structure of the fixing member engages with the counter locking structure when the cartridge reaches its final assembly position or while reaching such assembly position in the cartridge receiving space. Typically, engaging the fixing structure of the fixing member with the counter locking structure provides and results in a longitudinal or axial engagement and thus a longitudinal fixation of the fixing member and thus of the cartridge to or inside the cartridge holder.

[0067] Generally, a method of assembling a cartridge assembly can be performed by utilizing a cartridge assembly as described above and by utilizing a fixing member as described above, and therefore all of the features, advantages, and benefits described above associated with the fixing member and the cartridge assembly apply to the method of assembling a cartridge assembly as well.

[0068] According to another aspect, the present disclosure also relates to a drug delivery device, for example implemented as an injection device, such as a pen-type injector. The drug delivery device comprises a body, for example in the form of a proximal housing component. The body or the proximal housing component is usually connectable to a cartridge assembly as described above. The drug delivery device typically comprises a drive mechanism comprising a piston rod that exerts a dosing force on a piston located inside the body and a piston located inside the body, for example a tubular-shaped barrel of the cartridge, which is usually provided and / or fixed inside a housing component or cartridge holder of the cartridge assembly. Typically, the cartridge assembly is configured to be removably or non-removably connected and / or fixed to the body of the drug delivery device.

[0069] The drug delivery device typically comprises a cartridge assembly as described above. To that extent, all the features, advantages and benefits as described above for the cartridge assembly apply to the drug delivery device as well.

[0070] In some examples of the drug delivery device or cartridge assembly, the fixing member may be mechanically coded to the cartridge or to the type of cartridge, such that one of a plurality of available, differently configured fixing members may be selected according to the size of the cartridge and / or according to the type of drug contained in the cartridge.

[0071] The differently configured securing members may be distinguished from each other by at least one of the fastening portion, the securing structure, and the alignment portion. For example, a first securing member may be configured for engagement only with a first type of cartridge. The first securing member may comprise an alignment portion of a first configuration, which is exclusively suitable for insertion into the first housing component of a plurality of differently configured or available housing components. The first housing component may be mechanically coded to exclusively connect only to one of a plurality of available bodies or drive mechanisms of the drug delivery device. Thus, the differently coded housing components or the differently coded cartridge holders may be distinguished from each other by the shape and / or geometry of the cartridge receiving space, by the shape and / or configuration of the counter securing structure, and / or by the shape and / or configuration of the counter alignment structure.

[0072] In effect, the first type of cartridge intended for exclusive use with the first cartridge holder intended for exclusive use with the first body or drive mechanism of the drug delivery device can be unique and can be exclusively inserted and fastened to the cartridge holder via the fixing member. In this way, the fixing member attached to the first type of cartridge can effectively block and prevent the insertion of this cartridge into any other cartridge holder, for example into a second type of cartridge holder. The second type of cartridge holder can be exclusively dedicated to the second type of body or drug delivery device or can be exclusively connectable to the second type of body or drug delivery device, which is dedicated to interacting with a different cartridge, for example a second type of cartridge.

[0073] A cartridge assembly comprising a cartridge, a cartridge holder and a fixing member, in which the cartridge is permanently fixed or fixable inside the cartridge holder via a fixing member, can be manufactured and assembled by a pharmaceutical manufacturer. Such a cartridge assembly may be commercially distributed for a reusable drug delivery device. The cartridge holder of the cartridge assembly and the body of the drug delivery device may be mechanically coded to prevent unintended cross-use, i.e., to prevent use of a first type of body and / or drive mechanism with a second type of cartridge or cartridge holder that is not intended for use with this particular body or drive mechanism. By providing a cartridge assembly with a cartridge that is substantially fixed inside the drug delivery device, patient safety can be enhanced and misuse of the drug delivery device can be effectively prevented.

[0074] Generally, the scope of the present disclosure is defined by the content of the claims. The injection device is not limited to specific embodiments or examples, but includes any combination of elements of different embodiments or examples. To that extent, the present disclosure covers any combination of the claims and any technically feasible combination of features disclosed in relation to the different examples or embodiments.

[0075] In the present context, the term "distal" or "distal end" refers to the end of the injection device that faces towards the injection site of a person or animal, whereas the term "proximal" or "proximal end" refers to the opposite end of the injection device that is furthest from the injection site of a person or animal.

[0076] The terms "drug" or "medicament" are used synonymously herein to refer to a pharmaceutical formulation containing one or more active pharmaceutical ingredients or pharma- ceutically acceptable salts or solvates thereof, and optionally a pharma- ceutically acceptable carrier. An active pharmaceutical ingredient ("API"), in the broadest sense, is a chemical structure that exerts a biological effect on humans or animals. In pharmacology, drugs or medicines are used to treat, cure, prevent, or diagnose disease, or otherwise improve physical or mental health. Drugs or medicines may be used for a limited duration or periodically for chronic diseases.

[0077] As described below, a drug or pharmaceutical product may include at least one API or a combination thereof in various types of formulations for the treatment of one or more diseases. Examples of APIs may include small molecules with molecular weights of 500 Da or less, polypeptides, peptides and proteins (e.g., hormones, growth factors, antibodies, antibody fragments and enzymes), carbohydrates and polysaccharides, as well as nucleic acids, 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 molecular delivery systems such as vectors, plasmids or liposomes. Mixtures of one or more drugs are also contemplated.

[0078] The drug or agent may be placed in a primary package or "drug container" adapted for use with the drug delivery device. The drug container may be, for example, a cartridge, syringe, reservoir, or other sturdy or flexible vessel configured to provide a suitable chamber for storage (e.g., short-term or long-term storage) of one or more drugs. For example, in some cases, the chamber may be designed to store the drug for at least one day (e.g., from one day to at least 30 days). In some cases, the chamber may be designed to store the drug for about one month to about two years. Storage may be at room temperature (e.g., about 20°C) or at refrigerated temperatures (e.g., from about -4°C to about 4°C). In some cases, the drug container may be or include a dual-chamber cartridge configured to separately store two or more components of a pharmaceutical formulation to be administered (e.g., an API and a diluent or two different drugs), one in each chamber. In such cases, the two chambers of the dual chamber cartridge may be configured to allow mixing between the two or more components prior to and / or during administration into the human or animal body. For example, the two chambers may be configured such that they are in fluid communication with each other (e.g., by a conduit between the two chambers), allowing the user to mix the two components if desired prior to administration. Alternatively or additionally, the two chambers may be configured to allow mixing upon administration of the components into the human or animal body.

[0079] The drugs or agents contained in the drug delivery device as described herein may be used for the treatment and / or prevention of many different types of medical disorders. Examples of disorders include, for example, diabetes mellitus or complications associated with diabetes mellitus, such as diabetic retinopathy, thromboembolism, such as deep vein thromboembolism or pulmonary thromboembolism. Further examples of disorders include acute coronary syndromes (ACS), angina pectoris, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis. Examples of APIs and drugs are those listed in handbooks such as the Rote Liste 2014, such as, but not limited to, main groups 12 (antidiabetic drugs) or 86 (oncology drugs), and the Merck Index 15th Edition.

[0080] Examples of APIs for the treatment and / or prevention of type 1 or type 2 diabetes mellitus or complications of type 1 or type 2 diabetes mellitus include insulin, e.g. human insulin, or insulin analogs or derivatives, glucagon-like peptides (GLP-1), GLP-1 analogs or GLP-1 receptor agonists, or analogs or derivatives thereof, dipeptidyl peptidase-4 (DPP4) inhibitors, or pharma-ceutically acceptable salts or solvates thereof, or any mixtures thereof. As used herein, the terms "analog" and "derivative" refer to a polypeptide having a molecular structure that can be derived formally from the structure of a naturally occurring peptide, e.g., that of human insulin, by deleting and / or substituting at least one amino acid residue present in the naturally occurring peptide and / or by adding at least one amino acid residue. The added and / or substituted amino acid residues can be either 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 derivable from the structure of a naturally occurring peptide, such as the structure of human insulin, in which one or more organic substituents (e.g., fatty acids) are attached to one or more of the amino acids. Optionally, one or more amino acids found in the naturally occurring peptide may be deleted and / or replaced by other amino acids, including non-codable amino acids, or amino acids, including non-codable amino acids, may be added to the naturally occurring peptide.

[0081] Examples of insulin analogues 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 in position B28 can be replaced by Asp, Lys, Leu, Val or Ala and in position B29 Lys can be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0082] Examples of insulin derivatives are e.g. B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir®); B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl-LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin. B29-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) human insulin, B29-N-omega-carboxypentadecanoyl-gamma-L-glutamyl-des(B30) human insulin (insulin degludec, Tresiba®); B29-N-(N-lithocholyl-gamma-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0083] Examples of GLP-1, GLP-1 analogs and GLP-1 receptor agonists include, for example, lixisenatide (Lyxumia®), exenatide (exendin-4, Byetta®, Bydureon®, a 39 amino acid peptide produced by the salivary glands of the flatfish), liraglutide (Victoza®), semaglutide, taspoglutide, albiglutide (Syncria®), dulaglutide (Trulicity®), rExendin-4, CJC-1134-PC, PB-1023, TTP-054, langrenatide / HM-11260C (efpegrenatide), HM-15211, C M-3, GLP-1 Erigen, ORMD-0901, NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, Nodexene, Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR709, ZP-2929, Z P-3022, ZP-DI-70, TT-401 (pegapamoditide), BHM-034, MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, tirzepatide (LY3298176), bamadutide (SAR425899), exenatide-XTEN and glucagon-Xten.

[0084] An example of an oligonucleotide is, for example, the cholesterol-lowering antisense therapeutic mipomersen sodium (Kynamro®) for the treatment of familial hypercholesterolemia or RG012 for the treatment of Alport Syndrome.

[0085] Examples of DPP4 inhibitors are linagliptin, vildagliptin, sitagliptin, denagliptin, saxagliptin, berberine.

[0086] Examples of hormones include pituitary or hypothalamic hormones or regulatory active peptides such as gonadotropins (follitropin, lutropin, chorion gonadotropin, menotropin), somatropine (somatropin), desmopressin, terlipressin, gonadorelin, triptorelin, leuprorelin, buserelin, nafarelin and goserelin, and their antagonists.

[0087] Examples of polysaccharides include glycosaminoglycans, hyaluronic acid, heparin, low molecular weight heparin, very low molecular weight heparin or derivatives thereof or sulfated forms of the above polysaccharides, such as polysulfated forms, 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 (Synvisc®), sodium hyaluronate.

[0088] The term "antibody" as used herein refers to an immunoglobulin molecule or an antigen-binding portion thereof. Examples of antigen-binding portions of an immunoglobulin molecule include F(ab) and F(ab')2 fragments that retain the ability to bind to an antigen. The antibody may be a polyclonal antibody, a monoclonal antibody, a recombinant antibody, a chimeric antibody, a deimmunized or humanized antibody, a fully human antibody, a non-human (e.g., murine) antibody, or a single chain antibody. In some embodiments, the antibody has effector functions and is capable of fixing complement. In some embodiments, the antibody has reduced or no binding ability to Fc receptors. For example, the antibody may be an isotype or subtype, an antibody fragment, or a mutant that does not support binding to Fc receptors, e.g., with a mutation or deletion of the 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 crossover binding region orientation (CODV).

[0089] The term "fragment" or "antibody fragment" refers to a polypeptide (e.g., antibody heavy and / or light chain polypeptide) derived from an antibody polypeptide molecule that does not include a full-length antibody polypeptide but comprises at least a portion of a full-length antibody polypeptide that is still capable of binding to an antigen. An antibody fragment may include truncated portions of a full-length antibody polypeptide, but the term is not limited to such truncated fragments. Antibody fragments useful 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, such as bispecific, trispecific, tetraspecific and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent or multivalent antibody fragments, such as bivalent, trivalent, tetravalent and multivalent antibodies, minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camelized antibodies and VHH-containing antibodies. Additional examples of antigen-binding antibody fragments are known in the art.

[0090] The term "complementarity determining region" or "CDR" refers to short polypeptide sequences within the variable regions 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 regions of both heavy and light chain polypeptides that are not CDR sequences but are primarily responsible for maintaining the proper arrangement of the CDR sequences to allow antigen binding. Although the framework region itself typically does not directly participate in antigen binding, as is known in the art, certain residues within the framework region of a particular antibody may be directly involved in antigen binding or may affect the ability of one or more amino acids within the CDR to interact with the antigen.

[0091] Examples of antibodies are anti-PCSK-9 mAb (e.g., alirocumab), anti-IL-6 mAb (e.g., sarilumab), and anti-IL-4 mAb (e.g., dupilumab).

[0092] Pharmaceutically acceptable salts of any of the APIs described herein are contemplated for use in the drug or pharmaceutical preparation in the drug delivery device. Pharmaceutically acceptable salts include, for example, acid addition salts and base salts.

[0093] It will be understood by those skilled in the art that modifications (additions and / or deletions) may be made to the various components of the APIs, formulations, devices, 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.

[0094] Exemplary drug delivery devices may include needle-based injection systems as described in Table 1 of Section 5.2 of ISO 11608-1:2014(E). As described in ISO 11608-1:2014(E), needle-based injection systems may be broadly divided into multi-dose container systems and single-dose (with partial or complete evacuation) container systems. The container may be an exchangeable container or may be an integrated non-exchangeable container.

[0095] As further described in ISO 11608-1:2014(E), a multi-dose container system may include a needle-based injection device with an exchangeable container. In such a system, each container holds multiple doses and the size may be fixed or variable (pre-set by the user). Another multi-dose container system may include a needle-based injection device with an integrated non-exchangeable container. In such a system, each container holds multiple doses and the size may be fixed or variable (pre-set by the user).

[0096] As further described in ISO 11608-1:2014(E), the single-dose container system may include a needle-based injection device with a replaceable container. In one example of such a system, each container holds a single dose, which causes the entire deliverable volume to be expelled (full expulsion). In a further example, each container holds a single dose, which causes a portion of the deliverable volume to be expelled (partial expulsion). As also described in ISO 11608-1:2014(E), the single-dose container system may include a needle-based injection device with an integrated non-replaceable container. In one example of such a system, each container holds a single dose, which causes the entire deliverable volume to be expelled (full expulsion). In a further example, each container holds a single dose, which causes a portion of the deliverable volume to be expelled (partial expulsion).

[0097] Furthermore, it will be apparent to those skilled in the art that various modifications and changes can be made to the present disclosure without departing from the scope of the present disclosure. Furthermore, it should be noted that any reference signs used in the appended claims should not be construed as limiting the scope of the present disclosure.

[0098] In the following a number of examples of the use of injection devices as well as data logging devices for monitoring the respective injection devices will be described in more detail with reference to the drawings. [Brief description of the drawings]

[0099] [Figure 1] 1 illustrates a schematic diagram of an example of a drug delivery device. [Diagram 2] 1 shows a cartridge in which a fixing member is provided; [Diagram 3] 1 shows a cartridge assembly comprising a cartridge holder and a cartridge provided with a fixing member prior to insertion into the cartridge receiving space; [Figure 4] FIG. 2 is a perspective view of a separated fixing member. [Diagram 5] FIG. 5 is a side view of the fixing member of FIG. [Figure 6] FIG. 11 is another side view of the fixing member. [Figure 7] FIG. [Figure 8] FIG. 13 is a perspective view of a housing component implemented as a cartridge holder. [Figure 9] FIG. 9 is a partial cutaway view of a distal portion of the cartridge assembly of FIG. 8. [Figure 10] 10 is a cross-sectional view of the cartridge assembly of FIG. 9. [Figure 11] 1 is a longitudinal cross-section of a cartridge assembly. [Figure 12] FIG. 12 is an enlarged illustrative view of a distal portion of the cartridge assembly of FIG. 11. [Figure 13] 1 is a flow chart of an assembly method. [Figure 14] 1 is another longitudinal cross-section of the cartridge assembly. [Figure 15] FIG. 15 is an enlarged view of the distal portion of the illustration in FIG. 14. [Figure 16] FIG. 16 is another explanatory view of the cross section of FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0100] FIG. 1 shows an example of a drug delivery device 1 implemented as a pen-type injector. The drug delivery device 1 comprises a number of housing components. In detail, the drug delivery device 1 comprises a tubular-shaped housing component 30 implemented as a cartridge holder 31 dimensioned to accommodate a medicament container 5, such as the cartridge 10 shown in FIG. 2. The drug delivery device 1 further comprises a body 6 forming or constituting a proximal housing component 6. The body 6 accommodates a drive mechanism 7. The drive mechanism 7 may comprise a dose member 8 and / or a trigger 9 for setting and / or expelling a dose of a medicament 26 contained in the medicament container 5, which in this case may be implemented as a cartridge 10. Typically, the drive mechanism 7 comprises, for example, a piston rod 80 provided at its distal end with a pressure piece 81. The pressure piece 81 is configured to abut in the longitudinal direction (z) against a proximal end face of a piston 25 slidably arranged inside the barrel 11 of the cartridge 10. The piston 25 is shown, for example, in FIG. 11.

[0101] Barrel 11, which may be of a vitreous material such as glass, comprises a sidewall 12 having a generally tubular shaped main portion 14. A piston 25 is slidably displaceable along main portion 14. Towards the dosing end 27, main portion 14 merges into a narrowing shoulder 16, which in turn merges into a radially stepped down neck 16. Neck 16 terminates in a head 18, which may, at least on its outer surface, be provided with a somewhat radially expanded cross section compared to the neck.

[0102] The drug delivery device 1 further comprises a protective cap 4 configured to cover the dosing end 27 of the drug delivery device 1. Typically, the housing component 30 is implemented as a cartridge holder 31. The housing component 30 comprises a distal end 43 and a proximal end 44. The distal end 43 is configured to engage with a needle assembly, e.g., a double-tipped injection needle, via which a dose of the liquid medicament 26 can be injected into living tissue. To this end, the distal end 43 of the cartridge holder 31 comprises a threaded section 49 that supports and allows a threaded connection with a complementary shaped needle hub provided with the injection needle.

[0103] The distal end 43 of the cartridge holder 31 further comprises an aperture 50 for receiving a proximal portion or proximal extension of a dual-tipped injection needle. The injection needle is configured to pierce and / or penetrate a seal 20 at the distal end of the cartridge 10. The seal 20 may comprise a pierceable septum 21, which is secured to the distal head 18 of the cartridge via a septum retainer 22. The septum retainer 22 may comprise a beaded cap 23 made from a flexible material such as aluminum or plastic.

[0104] The septum retainer 22 includes an aperture 24 that aligns with the aperture 50 when the cartridge 10 is received inside the cartridge holder 31. Inside the cartridge holder 31, a cartridge receiving space 33 is provided, which is effectively occupied by the cartridge 10 when assembled inside the cartridge holder 31. The cartridge holder 31 includes a proximal end 44, which may be provided with an insert 52 that is dimensioned and configured for insertion into a receptacle 82, such as is provided at the distal end of the body 6. With respect to the distal direction 2, the insert 52 is bounded by a flange portion 55. The flange portion 55 may abut longitudinally against a distal end face of a side wall of the receptacle 82 when the cartridge holder 31 is attached to the body 6.

[0105] On the inside of the receptacle 82 there may be provided a counter-fastening structure 83, for example in the form of a radial protrusion or a radial recess, which engages with a complementary fastening element 53 as provided on the outer surface of the insert 52. In this way, the proximal end 44 of the cartridge holder 31 can be fixed and attached to the body 6.

[0106] Optionally, the proximal end 44 of the cartridge holder 31 may comprise a coding element 54, via which the cartridge assembly 150 may be mechanically encoded, for example to distinguish it from another cartridge assembly 150 comprising a different type of cartridge 10 or a cartridge containing a different medicament 26. The coding element 54 or coding feature may be complementary in shape or positioned to a counter-coding element 84 as provided on or inside the body 6. A mismatched pair of coding element 54 and counter-coding element 84 may prevent mutual fastening of the cartridge holder 31 to the body 6.

[0107] Mutual fastening and fixing of the cartridge holder 31 to the main body 6 may be provided and enabled only when the size, shape and position of the coding element 54 of the cartridge holder 31 matches a corresponding counter coding element 84 provided on or inside the main body 6.

[0108] In one embodiment, the present disclosure relates to a cartridge assembly 150 comprising a cartridge holder 31, a cartridge 10 and a fixing member 100. The fixing member 100, shown in more detail in Figs. 4-7, comprises a body 101. The fixing member 100, in particular its body 101, may be a single joined or unitary component. The fixing member 100 is provided separately from the cartridge 10. It can be fastened to the cartridge 10, in particular to the neck 16 of the barrel 11 of the cartridge 10. To fasten the fixing member 100 to the cartridge 10, the fixing member comprises a fastening portion 110. The fastening portion 110 is configured to fasten the entire fixing member 100 to the neck 16 of the cartridge 10.

[0109] In the example shown in Figs. 4-7, the fastening portion 110 comprises a fastening ring 111. The fastening ring 111 is generally annular in shape. It is interrupted by a slit opening 112, thereby dividing the fastening ring into a first ring portion 113 and a second ring portion 114. The first ring portion 113 and the second ring portion 114 are interconnected by an intermediate portion 115. The first ring portion 113, the intermediate portion 115, and the second ring portion 114 may comprise an incomplete annular shape extending tangentially or circumferentially from about 210° to 300°. In the currently shown example, the tangential extent of the fastening ring 111 is about 270°. The size of the slit opening 112 is slightly smaller than the diameter of the neck 60 of the cartridge 10. The fastening ring 111 may be flexible or elastically deformable to some extent to allow clip fastening onto the neck 16 of the cartridge 10.

[0110] The fixing member 100 further comprises a fixing structure 120. The fixing structure 120 is configured to fix the fixing member 100 inside the cartridge receiving space 33, as shown in Fig. 11. To this end, the fixing structure 120 comprises at least a first fixing element 121, which is configured to engage with a counter fixing structure 60 of the housing component 30, and thus of the cartridge holder 31. Furthermore, the fixing member 100 comprises an alignment portion 130. The alignment portion 130 is configured to align with a counter alignment structure 34, which is provided on or in the side wall 32 of the cartridge holder 31.

[0111] As becomes clear from the illustrations of the various figures 1 to 16, the fixing member 100 is configured for fastening to the distal part of the cartridge 10. It is then configured for insertion into and through an insertion opening 48 of the cartridge holder 31, which insertion opening 48 is provided at or near the proximal end 44 of the cartridge holder 31. Consequently, as shown for example in figure 11, when the cartridge 10 reaches the final assembled position, the fixing member 100 is located at or near the distal end 43 of the cartridge holder 31, where the cartridge holder 31 comprises a counter fixing structure 60 which engages with a fixing structure 120 as provided on the fixing member 100.

[0112] As the fixing member 100 is configured for insertion into the cartridge receiving space 33, it may be difficult to achieve that the fixing structure 120 obtains proper alignment with the counter fixing structure 60. For this purpose, the alignment portion 130 is configured to engage with a counter alignment structure 34 as provided on the inner side 41 of the side wall 32 of the cartridge holder 31. The alignment portion 130, which is positionally fixed relative to the fixing structure 120, may be and remain in keyed engagement with the side wall 32 of the cartridge holder 31 during and for insertion of the cartridge 10 into the cartridge holder 31. The keyed engagement between the alignment portion 130 and the counter alignment structure 34 rotationally locks the fixing member 100 relative to the cartridge holder 31 and guides the fixing structure 120 longitudinally into engagement with the counter fixing structure 60 of the cartridge holder 31.

[0113] As shown in more detail in Figures 4-7, the alignment portion 130 comprises a radial projection 131 that projects radially outward from the outer surface 116 of the fastening portion 110. In this way, the alignment portion 130 provides a symmetry breaking of the fastening portion 110 and thus of the fastening ring 111. As shown in Figure 4, the alignment portion 130 projects longitudinally from the plane of the fastening ring 111. As shown in particular in Figure 2, the alignment portion 130 projects towards the proximal end of the cartridge 10 when the fixing member 100 is fastened and attached to the neck 16. In this way, the fixing elements 121, 122 provided on the outer surface of the fastening portion 110, in particular on the outer surfaces of the first ring portion 113 and the second ring portion 114, are oriented in the correct direction.

[0114] The alignment portion 130 further comprises a longitudinal extension 138 that projects longitudinally from the fastening portion 110. The longitudinal extension 138 provides a symmetry breaking function for the fastening ring 111. When attached to the cartridge, the longitudinal extension 138 must project from the fastening portion in the proximal direction 3. In this way, the fixation structure 120 is correctly oriented in the longitudinal direction (z). Furthermore, the longitudinal extension 138 may also serve as a handle to facilitate gripping and / or fastening the fixation member 100 to the cartridge 10.

[0115] As shown in particular in Figures 4-7, the fixing structure 120 comprises a first fixing element 121 provided on the first ring part 113. The fixing structure 120 further comprises a second fixing element 122 provided on the second ring part 114. The fixing elements 121, 122 are implemented as snap elements 123. They comprise a radially outwardly projecting nose 124 or nose part having an abutment surface 125 facing in the proximal direction 3 and thus pointing towards the alignment part 130. In the opposite axial direction, i.e. towards the distal direction 2, the fixing elements 121, 122 each comprise an inclined edge 126 or inclined side surface. The inclined edge extends radially outward and merges into a radially stepped down abutment surface 125.

[0116] On the outwardly facing part of the fixing member 100, the alignment part 130 merges into the fastening part 110 via a shoulder 135. The shoulder 135 has a stepped profile and a distally facing abutment surface 136, via which the fixing member 100 adapts to the shape of the inner surface of the shoulder 45 of the side wall 32 of the cartridge holder 31. As shown in Fig. 15, the cartridge holder 31 comprises a side wall 32 with a tubular shaped main part 47 which merges into a radially stepped down neck 46 provided with a threaded section 49. The tubular or main part 41 of the side wall 32 radially narrows into the neck 46 via the shoulder 45.

[0117] As shown in more detail in FIG. 15, the outward shape of the shoulder 135 of the fixing member 100 is complementary to the inner shape of the shoulder 45 of the side wall 32 of the cartridge holder 31 .

[0118] 15, the inner surface 139 of the extension 138 of the alignment portion 130 is shaped and configured to abut the shoulder 15 of the barrel 11 of the cartridge 10. Thus, when reached in the final assembled position, the locking member 100 not only provides longitudinal locking of the cartridge 10 inside the cartridge holder 31, but also provides a well-defined axial or longitudinal abutment between the outwardly facing shoulder 15 of the cartridge 10 and the inwardly facing shoulder 45 of the cartridge holder 31.

[0119] As shown in particular in Fig. 7, the alignment portion 130 projects radially outward from the annular shape of the fastening portion 110. The alignment portion 130, in particular the entire longitudinal extension 138, comprises an inclined outer surface 132, another inclined outer surface 134 and a further outer surface 133 located between the two inclined outer surfaces 132, 134. In the cross section of Fig. 7, the outer surfaces 132, 133, 134 are trapezoidal or form a trapezoidal profile of the extension 138. Here, in general, any other geometrical profile may also be used that allows a mechanical coding of the fixing member 100 and the cartridge holder 31.

[0120] At least one alignment recess 42 is provided on the inside of the side wall 32 of the cartridge holder 31, the alignment recess 42 being complementary in shape to the cross section of the alignment portion 130. The alignment portion 130, which aligns with the alignment recess 42, is particularly shown in FIG. 10. In FIG. 10, a particular example of a cartridge holder 31 is shown, in which the side wall 32 deviates slightly from a cylindrical cross section. Here, the side wall 32 comprises a first side wall section 35, a second side wall section 37 and a third side wall section 39. Each side wall section 35 comprises, when viewed from the outside, a convex panel or a slant profile. Each side wall section 35, 37, 39 may comprise a continuous profile extending in the longitudinal direction. The first side wall section 35 merges into the second side wall section 37 along a ridge 36. The second sidewall section 37 merges along a second ridge 38 into a third sidewall section 39 which merges into the first sidewall section 35 along a third ridge 40 .

[0121] In the cross section of FIG. 10, two further alignment recesses 42', 42'' are shown located radially inward from the second ridge 38 and the third ridge 40. The alignment recesses 42 may be similarly suitable for receiving the alignment portion 130. Thus, the side wall 32 of the cartridge holder 31 may provide and support three different alignment configurations of the fixing member 100 relative to the holder 31. The different alignment configurations may be transformed into one another by a rotation of about 120° about the central axis of the cartridge 10 as an imaginary axis of rotation.

[0122] As is further evident from Figures 8 and 9, the counter-fixing structure 60 comprises at least two counter-fixing elements 61, 62, which in this embodiment are configured as recesses 63 in the side wall 32 of the cartridge holder 31. The counter-fixing elements 61, 62 are provided as recesses 63 on the inner surface 41 of the side wall 32. They are implemented as through-holes 64 as shown in Figure 8. The counter-fixing elements 61, 62 may be in geometrically opposed positions to engage with radially outwardly protruding fixing elements 121, 122 of the fixing structure 120 of the fixing member 110. A respective plurality of counter-fixing elements 61, 62 may be provided according to a plurality of available alignment recesses 42, 42', 42'' on or along the inner surface 41 of the side wall 32.

[0123] In a further example where only a first counter fixing element 61 and a second counter fixing element 62 are provided, only one alignment recess 42 may be provided on the inner side 41 of the side wall 32, thereby performing only a dedicated alignment or orientation of the fixing member 100 relative to the internal keying or coding structure of the side wall 32 of the cartridge holder 31.

[0124] The alignment recess 42 may extend across the entirety of the main portion 47 of the side wall 32 of the cartridge holder 31. It may be adjacent to an insertion opening 48 through which a fixing member 100 attached to the cartridge 10 is inserted in the distal longitudinal direction 2 into the cartridge receiving space 33. While the alignment portion 130 engages and remains engaged with a counter alignment structure 34, e.g., the alignment recess 42, a keyed and anti-rotational engagement between the fixing member 100 and the cartridge holder 31 is provided.

[0125] 11 and 14, the distally facing angled edges 126 of the fixing elements 121, 122 may begin to slide along the complementary angled edges 56 that project radially inwardly from the inner surface 41 of the sidewall 32 at locations longitudinally adjacent the locations of the counter fixing elements 61, 62. In this manner, the sidewall 32 may undergo a slight outward deformation until the angled edges 126 or sides of the fixing elements 121, 122 clear the inwardly projecting angled edges 56 or sides.

[0126] When the inclined edge 126 passes longitudinally over the inclined edge 56, the proximally facing abutment surfaces 125 of the fixing elements 121, 122 abut longitudinally against the distally facing abutment surfaces 65 of the counter fixing elements 61, 62, thereby preventing proximal displacement and thus removal of the fixing member 100 in the proximal direction 3 from the cartridge receiving space 33.

[0127] A user attempting to pull the cartridge 10 out of the cartridge holder 31 in the proximal direction 3 causes the effect of a proximal force of the head 18 to abut against the distally facing side of the fastening ring 111. The effect of the respective proximal force is thus transmitted to the fastening portion 110, which force is counteracted by the distally facing abutment surface 65 of the counter-locking structure 60.

[0128] In some examples of the cartridge assembly 150, the counter-fixing structure 60 is provided with one or more through holes 64 that are accessible from the outside, and it is generally considered that deformation of at least one of the fixing elements 121, 122 and the counter-fixing structure 60 can be caused, for example by means of a dedicated tool, so as to cancel the axial or longitudinal fixed abutment between the abutment surfaces 65 and 125.

[0129] Towards the distal end of cartridge 10, for example, a distal end face of septum retainer 22 may abut end wall 57 of cartridge holder 31. Furthermore, as described above in connection with FIG. 15 , fixation member 100 may provide a distally acting abutment between distally facing shoulder 15 of barrel 11 of cartridge 10 and proximally facing shoulder 135 of cartridge holder 31, respectively.

[0130] In the flow chart of Fig. 13, a method of assembling a cartridge assembly 150 as described herein is further described. In a first step 200, the fixing member 100 is fastened to the neck of the cartridge 10, where the fastening ring 111 may be clipped to the radially narrowing neck 16. Then, in step 201, the assembly of the fixing member attached to the cartridge is aligned and oriented such that the alignment portion 130 of the fixing member 100 aligns with a counter alignment structure 34 such as provided on or inside the side wall 32 of the cartridge holder 31.

[0131] Once correctly aligned, for example so that the radial protrusion 131 of the alignment portion 130 is oriented and aligned with a longitudinally extending alignment recess 42 provided on the inner surface 41 of the side wall 32, the cartridge 10 provided with the fixing member 100 can be inserted longitudinally toward the distal end 43 of the cartridge holder 31 into the cartridge receiving space 33 in step 202.

[0132] Thereafter, upon or before reaching the final assembly position, the locking structure 120 of the locking member 100 engages with the counter locking structure 60 in step 203. Here, as shown in Fig. 12, the radially outwardly extending and protruding snap elements 123 of at least one of the first locking element 121 and the second locking element 122 mechanically engage with the recesses 63 of the counter locking elements 61, 62, thereby preventing and blocking proximal removal of the cartridge 10 from the cartridge receiving space 33. [Explanation of symbols]

[0133] 1. Drug Delivery Devices 2 Distal direction 3 Proximal direction 4 Protective cap 5. Drug containers 6 Main unit 7 Driving mechanism 8 Dosage components 9 Triggers 10 Cartridge 11 Barrel 12 Side wall 14 Main Section 15 Shoulder 16 neck 18 head 20 Seal 21 Septum 22 Septum holder 23 Beaded Cap 24 Aperture 25 Piston 26 Drugs 27 Medication End 30 Housing Components 31 Cartridge holder 32 Side wall 33 Cartridge receiving space 34 Counter alignment structure 35 Sidewall Section 36 Ridge 37 Sidewall Section 38 Ridge 39 Sidewall Section 40 Ridge 41 Inside 42 Alignment recess 43 Distal end 44 Proximal end 45 Shoulder 46 Neck 47 Main Section 48 Insertion part opening 49 Threaded Section 50 Aperture 52 Insertion section 53 Fastening elements 54 Coding Elements 55 Flange part 56 Sloped Edge 57 End Wall 60 Counter fixing structure 61 Counter fixing element 62 Counter fixing element 63 Recess 64 Through Hole 65 Contact surface 80 Piston rod 81 Pressure welding piece 82 Receptacle 83 Counter fastening structure 84 Counter Coding Elements 100 Fixing member 101 Main unit 110 Fastening part 111 Fastening ring 112 Slit opening 113 Ring Section 114 Ring section 115 Middle 116 Exterior 120 Fixed structure 121 Fixed elements 122 Fixed elements 123 Snap Elements 124 Nose 125 Contact surface 126 Sloped Edge 130 Alignment section 131 Convex 132 Exterior 133 Exterior 134 Exterior 135 Shoulder 136 Contact surface 138 Extension 139 Inside 150 Cartridge Assembly

Claims

1. A fixing member (100) for fastening to a cartridge (10), said cartridge (10) being configured for insertion into a housing component (30) of a drug delivery device (1), said housing component (30) comprising a side wall (32) defining a cartridge receiving space (33), said cartridge receiving space (33) extending in a longitudinal direction (z), a fastening part (110) for fastening to the neck (16) of said cartridge (10); a fastening structure (120) comprising a first fastening element (121) adapted to engage with a counter fastening structure (60) of said housing component (30); - an alignment portion (130) configured to align with a counter-alignment structure (34) provided on or in said side wall (32) of said housing component (31); The fixing member (100) comprises:

2. The fixing member (100) of claim 1, wherein the alignment portion (130) is configured to orient the fixing member (100) in at least one precise or dedicated orientation relative to the housing component (30) and / or relative to the counter fixing structure (60).

3. 3. The fixing member (100) of claim 1 or 2, wherein the counter alignment structure (34) extends along the longitudinal direction (z) and the alignment portion (130) is configured to engage and / or slide along the counter alignment structure (34).

4. The fixing member (100) according to any one of claims 1 to 3, wherein insertion of the fixing member (100) into the housing component (30) when fastened to the neck (16) of the cartridge (10) is only possible by the alignment portion (130) being precisely aligned and precisely oriented with respect to the counter alignment structure (34).

5. The fixing member (100) according to any one of claims 1 to 4, wherein when the alignment portion (130) is misaligned with respect to the counter alignment structure (34), the fixing structure (120) cannot engage the counter fixing structure (60).

6. The fixing member (100) according to any one of claims 1 to 5, wherein the fixing structure (120) is configured to engage with the counter fixing structure (60) in the longitudinal direction (z) and fix the cartridge (10) relative to the housing component (30) with respect to the longitudinal direction (z).

7. 13. The fixing member (100) of claim 12, wherein the alignment portion (130) comprises one of a radial convex portion (131) and a radial alignment recess (131) that engages with one of a complementary radial alignment recess (42) and a radial convex portion on an inner surface (41) of the side wall (32) of the housing component (30).

8. The fixing member (100) according to any one of claims 1 to 7, wherein the fastening portion (110) comprises a fastening ring (111) comprising a first ring portion (113) and a second ring portion (114) separated from each other by a slit opening (112).

9. The fastening member (100) of claim 8, wherein the fastening ring (111) comprises an intermediate portion (115) interconnecting the first ring portion (113) and the second ring portion (114).

10. The stationary member (100) of claim 9, wherein the alignment portion (130) is provided on an outer surface (116) of the intermediate portion (115).

11. The fixing member (100) according to any one of claims 8 to 10, wherein the fixing structure (120) further comprises a second fixing element (122), the first fixing element (121) being provided on the first ring portion (113) and the second fixing element (122) being provided on the second ring portion (114).

12. The fixing member (100) according to any one of claims 8 to 11, wherein the alignment portion (130) comprises a longitudinal extension (138) projecting in a longitudinal direction (z) from the fastening ring (111).

13. The fixing member (100) according to any one of claims 1 to 12, wherein the first fixing element (121) comprises a snap element (123) having an abutment surface (125) facing in a proximal longitudinal direction (3) for abutting a complementary abutment surface (65) of the housing component (30) and further comprising a beveled edge (126) facing in a distal longitudinal direction (2).

14. A cartridge assembly (150) for a drug delivery device (1), comprising: a cartridge (10) comprising a tubular barrel (11) containing a medicament (26), the cartridge (10) comprising a neck (16); a housing component (30) of the drug delivery device (1), a side wall (32) defining a cartridge receiving space (33) extending in a longitudinal direction (z); a counter fixing structure (60), - a counter alignment structure (34) provided on or in said side wall (32); A housing component (30) comprising: a fixing member (100) according to any one of claims 1 to 13, fastenable to said neck (16) and configured, when fastened to said neck (16) of said cartridge (10), to engage with said counter fixing structure (60) and to align with said counter alignment structure (34) upon insertion of said cartridge (10) into said cartridge receiving space (33); A cartridge assembly (150) comprising:

15. The cartridge assembly (150) of claim 14, wherein the housing component (30) comprises a cartridge holder (31) having a proximal end (44) configured for attachment to the body (6) of the drug delivery device (1), the proximal end (44) having an insertion opening (48) dimensioned to receive the cartridge (10) and the fixing member (100) attached to the cartridge (10) in only one or several orientations of the cartridge (10) and the fixing member (100) relative to the cartridge holder (31) with respect to the longitudinal direction (z) as a rotation axis.

16. A cartridge assembly (150) as described in claim 14 or 15, wherein the counter alignment structure (34) comprises a longitudinally extending alignment recess (42) on the inner surface (41) of the side wall (32), the longitudinally extending alignment recess (42) being complementary in shape to the radially outwardly protruding alignment portion (130) of the fixing member (100).

17. A cartridge assembly (150) according to any one of claims 14 to 16, wherein the counter fixing structure (60) provided in or on the side wall (32) is configured to engage with the first fixing element (121) of the fixing member (100) when the cartridge (10) provided with the fixing member (100) reaches its final assembly position inside the cartridge receiving space (33).

18. The cartridge assembly (150) of claim 17, wherein the first fixing element (121) is longitudinally aligned with the first counter fixing element (61) through alignment of the alignment portion (130) of the fixing member (100) with the counter alignment structure (34) of the side wall (32) when the cartridge (10) and the fixing member (100) are inserted into the cartridge receiving space (33).

19. A method of assembling a cartridge assembly (150) of a drug delivery device (1), comprising the steps of: - fastening a fixing element (100) according to any one of claims 1 to 13 on the neck (16) of the cartridge (10); - aligning said alignment portion (130) with a counter-alignment structure (34) provided on or in a side wall (32) of a cartridge holder (31) of said drug delivery device (1); - inserting said cartridge (10) and said fixing member (100) into a cartridge receiving space (33) of said cartridge holder (31); - said fastening structure (120) of said fastening member (100) engages with said counter fastening structure (60) when said cartridge (10) reaches its final assembly position in said cartridge receiving space (33); A method comprising:

20. A drug delivery device (1), comprising: a body (6), a drive mechanism (7) comprising a piston rod (80) arranged inside or attached to said body (6) and configured to exert a dosing force on a piston (25) located inside the barrel (11) of the cartridge (10); a cartridge assembly (150) connectable to said body (6) according to any one of claims 14 to 19; A drug delivery device (1).

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