Cartridge assembly and fixing member

Abstract

The present disclosure relates to a fixation member (100) for fixing a medicament container (5) within a housing component (30) of a drug delivery device (1), the housing component (30) including a housing side wall (32) surrounding a container receiving space (33) and extending in a longitudinal direction (z), the fixation member (100) comprising: - a fastening portion (110) including an inner surface (113) of a shape complementary to an outer surface (63) of the counter fastening portion (60) of the housing side wall (32), the inner surface (113) being sized and shaped to support at least one of longitudinal and circumferential fastening movement of the fastening portion (110) relative to the counter fastening portion (60) to reach a final assembled configuration; a fastening structure (120) connected to the fastening portion (110) and including a first fastening element (121), the first fastening element (121) configured to extend into the container receiving space (33) and mechanically engage with a medicament container (5) located within the container receiving space (33) when the fastening portion (110) reaches a final assembled configuration on the counter fastening portion (60); The present invention relates to a cartridge assembly including a fixing member (100).

Description

[Technical field]

[0001] The present disclosure relates to a cartridge assembly, in particular 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 with a cartridge or cartridge assembly, a drug delivery device, and a method of assembling the cartridge assembly. [Background technology]

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

[0003] Drug delivery devices such as pen 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 impaired 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] A patient suffering from a particular disease may need to inject a quantity of medication through a pen-type injection syringe or through a pump. For reusable injection or delivery devices, the patient may need to fill or replace the cartridge. Reusable injection devices typically include a multi-part housing. For example, the housing may include a proximal housing component, such as a body, and a distal housing component, such as a cartridge holder, that is removably connectable to the body. When the medication provided in the medication container, such as a cartridge, is emptied, the cartridge holder can be disconnected from the body of the injection device, and the empty cartridge can be removed and replaced with a new cartridge.

[0005] Another concern may arise that cartridges are manufactured in an essentially standard size and to comply with certain recognized local and international standards. As a result, such cartridges are typically supplied in standard size cartridges (e.g., 3 ml cartridges). Thus, there may be a variety of cartridges supplied by many different suppliers, containing different medicaments, but fitting into a single drug delivery device. As just one example, a first cartridge containing a first medicament 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 medicament into a drug delivery device and subsequently administer said medicament (such as rapid or basal insulin) without realizing that the medical delivery device is perhaps not designed or intended to be used with such a cartridge.

[0006] As such, there is an increasing desire from users, health care providers, caregivers, regulatory agencies, and medical device suppliers to reduce the potential risk that a user will load the wrong type of drug into a drug delivery device. It is also desirable to reduce the risk of administering the wrong drug (or the wrong concentration of 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 further removably or non-removably connectable to a dosing mechanism of such a drug delivery device.

[0008] A cartridge configured for insertion into a cartridge holder of a drug delivery device typically includes a tubular body integrated with a radially narrowed neck, which is further integrated with a distally located, radially wider 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 to the distal end of the head. In some approaches for fixing the cartridge to the cartridge holder, the cartridge holder includes radially inwardly protruding structures 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 structures of the cartridge holder, which may then result in mechanical and / or visual defects in the area of ​​the septum retainer of the cartridge.

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

[0010] In one aspect, the present disclosure relates to a fixing member for fixing a medicament container within a housing component of a drug delivery device. In some examples, the housing component is embodied as a cartridge holder. The medicament container may be embodied as a cartridge. The housing component includes a housing sidewall that encloses a container-receiving space. In some examples, the housing sidewall encloses the cartridge-receiving space. The housing sidewall extends in a longitudinal direction (z), which may also be denoted as an axial direction.

[0011] The securing member includes a fastener having an inner surface complementary in shape to an outer surface of a counter fastener of a housing sidewall of the housing component, the inner surface sized and shaped to support at least one of longitudinal and circumferential fastening movement of the fastener relative to the counter fastener to reach a final assembled configuration.

[0012] The securing member further includes a securing structure. The securing structure may be connected to the fastening portion. In some examples, the securing structure and the fastening portion are integrally formed, i.e., the securing structure and the fastening portion are substantially immovably and / or permanently connected to one another.

[0013] The securing structure includes a first securing element configured to extend into the container receiving space and mechanically engage a drug container located within the container receiving space when the fastening portion of the securing member reaches a final assembled configuration on the counter fastening portion.

[0014] In some examples, the inner surface of the fastener and the outer surface of the counter fastener are complementary shaped to provide for sliding movement of the fastener relative to the counter fastener from a pre-assembled configuration in which the fastener and counter fastener may engage, to a final assembled configuration in which the fixing structure of the fixing member mechanically engages with a drug container located within the container receiving space of the housing component.

[0015] In this way, the fastening member is suitable for mounting and / or fixing to the outside of the drug container, since the inner surface of the fastening portion matches the outer surface of the counter-fastening portion. It is no longer necessary to modify the inner or internal structure of the drug container in order to provide a mechanical fixation of the drug container in the container-receiving space. By means of the fastening member mountable to the outside of the housing component and by means of the fastening structure extending into the container-receiving space, a fairly easy, straightforward, cost-effective and durable solution for fixing and / or holding the drug container in the container-receiving space of the housing component can be provided.

[0016] The fixing member can be fastened to the outside of the housing component of the drug delivery device via the fastening portion. The fixing member can mechanically interact with the drug container via the fixing structure when the drug container is located in the container receiving space of the housing component. The fixing structure can be configured to securely engage with the outside of the drug container. The fixing structure can engage with a recessed portion of the drug container, for example with a neck of the drug container.

[0017] According to a further example, the fixing structure of the fixing member is configured to longitudinally engage with a recessed portion of the drug container when the drug container is located in the container accommodating space, e.g., in a final assembly position in the container accommodating space, and when the fixing member reaches a final assembly configuration or final assembly position on the housing component.

[0018] In some examples, the securing structure is configured to longitudinally abut a complementary shaped counter securing structure on the medicament container. In this manner, the medicament container can be retained and / or secured in a final longitudinal position within the container receiving space. When the securing structure engages the medicament container, the medicament container is typically secured or fixed against longitudinal movement relative to the housing component. When engaged with the securing structure, the medicament container can be secured against proximal removal from the medicament container.

[0019] In some examples, the fixing member is provided as a separate part configured to releasably or non-releasably attach to a housing component of a drug delivery device. In this way, the fixing member can be retrofitted to an existing housing component or an existing drug delivery device to provide a cartridge assembly including a housing component embodied as a cartridge holder and a drug container embodied as a cartridge, the fixing member being as described herein configured to fix the cartridge within a cartridge receiving space of the cartridge holder.

[0020] By providing the fastening member as a separate part mountable to the outside of the housing component, the drug container can be assembled or placed in the container-receiving space before the fastening member is attached or fastened to the housing component, In this way, the inside of the container-receiving space can be embodied without any radially inwardly extending protrusions that may impair the integrity, functionality or appearance of the drug container.

[0021] Attaching the fixing member to the housing component or cartridge holder after insertion of the medicament container or cartridge into the container receiving space provides the advantage of allowing a relatively easy, simple and unobstructed insertion of the medicament container into the container receiving space. The fixing structure, which extends into the container receiving space and interacts with the medicament container to fix it at least in the longitudinal direction, can be assembled and attached to the housing component after insertion of the container into the container receiving space, thereby avoiding adverse effects on relatively sensitive parts of the medicament container.

[0022] The inner surface of the fastening portion has a shape complementary to the outer surface of the counter fastening portion of the housing side wall, so that a pre-assembled configuration can be provided in which the fastening portion is mechanically attached to the counter fastening portion, but in the pre-assembled configuration the fixing structure does not yet extend into the container receiving space.

[0023] The mutually corresponding sides of the outer surface of the counter fastening portion and the inner surface of the fastening portion can enable early fastening or pre-fixing of the fixing member to the housing component and can enable and support sliding or gliding movement of the fixing member relative to the housing component towards the final assembly configuration where the fastening portion reaches the final assembly configuration on the counter fastening portion and the fixing structure mechanically engages with the drug container.

[0024] In a pre-assembled configuration of the securing member and the housing component, the securing structure may be located completely outside the container-receiving space, and may only start to extend into the container-receiving space when the securing member moves from a pre-assembled configuration or position towards or to a final assembled position or configuration, such that the securing structure assumes a longitudinal securing position or configuration for the cartridge when the securing member approaches or reaches the final assembled configuration on the housing component.

[0025] In this way, the fixing member can be pre-assembled to the housing component, e.g. to the cartridge holder, before the medicament container is placed in the container receiving space. Separate handling of the fixing member and the medicament container can thus be avoided and is no longer necessary. By pre-assembling the fixing member to the medicament container, the fixing member is easily provided on the medicament container and is already attached to the medicament container.

[0026] A user of the cartridge assembly or drug delivery device simply manually inserts the cartridge into the cartridge receiving space and moves the fixing member to its final assembly configuration or position, thereby establishing a mechanical interlock between the fixing member, the drug container and the housing components.

[0027] According to a further example, the fastening portion comprises an annular side wall. In this case, the complementary shaped counter fastening portion of the housing component may also be annular. The annular fastening portion may allow a longitudinal and / or rotational sliding or sliding support for moving the fastening portion and thus the fastening portion relative to the counter fastening portion to reach the final assembly configuration. The annular fastening portion is also beneficial for improving the stability and rigidity of the fastening portion.

[0028] The sidewall of the fastening member may also be tubular. The sidewall of the fastening member may include a sleeve-like structure and may fit over a complementary shaped annular or tubular outer surface of the counter fastener. The inner diameter of the sidewall of the fastener may approximately match the outer diameter of the complementary shaped annular or tubular structure of the outer surface of the counter fastener. In this way, a friction fit may be provided between the fastener and the counter fastener.

[0029] In some examples, the fastener can be clamped against the counter fastener, provided that the inner diameter of the sidewall of the fastener exactly matches the outer diameter or outer cross section of the outer surface of the counter fastener. In some examples, the sidewall of the fastener of the fixing member can be conical. The sidewall of the fastener of the fixing member can be complementary in shape to the corresponding conical shape of the counter fastener. The mutually corresponding conical shapes of the fastener and the counter fastener can provide a type of press-fit engagement between the fastener and the counter fastener.

[0030] According to a further example, the fastening portion of the fixing member includes an annular fastening ring. The fastening ring may include a circumferentially closed structure. Such a structure is relatively stable, robust and rigid. The annular fastening ring enables and supports longitudinal and rotational fastening actions for moving the fastening portion from a pre-assembly position or configuration, towards a final assembly position or configuration, and to a final assembly position or configuration.

[0031] In a further example, the fastener comprises a closed ring. In other examples, the fastener comprises a segmented or interrupted ring. A closed ring may provide a high degree of dimensional stability and provide durable clamping or fastening of the fastener to the counter fastener. A closed ring may require a relatively high assembly force, for example, to bring the closed ring into a press-fit configuration with the counter fastener.

[0032] In an open ring configuration, the fastening portion includes a relatively high degree of flexibility. In an open ring configuration, i.e. a ring interrupted by slits or through openings in its annular body, the ring can be easily elastically deformable in the radial direction to change its diameter. In this way, the fastening portion can be easily adapted to various shapes or geometric tolerances of the counter fastening portion of the housing component.

[0033] The open ring structure of the fastener may provide for relatively easy removal or disassembly of the securing member and the drug container. In either implementation, i.e., in fasteners including a closed ring structure or an open ring structure, the securing member may be permanently or removably securable or attachable to the housing component.

[0034] According to further examples of the fixing member, the inner surface of the fastening part includes a sliding surface configured to slide longitudinally and / or circumferentially over a complementary shaped counter sliding surface of the outer surface of the counter fastening part. In some examples, the pre-assembled position of the fixing member may be longitudinally offset from the final assembled configuration.

[0035] In another example, the pre-assembled configuration or pre-assembled position of the securing member may be circumferentially or rotationally offset from a final assembled configuration having the longitudinal axis of the container-receiving space as an axis of rotation. In a further example, the final pre-assembled position may be distinguished from the final assembled position by a longitudinal offset and a rotational offset.

[0036] Providing slide and counter slide surfaces on the interengaging inner and outer surfaces of the securing member and the housing component can provide a well-defined fastening action for moving the securing member from a pre-assembly position toward and to a final assembly position. In some examples, the slide and complementary shaped counter slide surfaces enable and support a fairly easy and smooth sliding or gliding of the securing member relative to the housing component.

[0037] In some examples, the slide surface and complementary shaped counter slide surface may provide, enable, or define a helical sliding or gliding motion of the securing member relative to the housing component to move the securing member from a pre-assembled configuration, toward and to the final assembled configuration.

[0038] In a further example, the mutually corresponding slide surfaces and counter slide surfaces also enable well-defined movement of the securing member from a final assembled configuration towards a pre-assembled configuration, to a pre-assembled configuration, or towards a separated configuration, where the securing member is removed from the housing component.

[0039] According to a further example, the first locking element is at least one of elastically movable and elastically deformable relative to the fastening portion in the radial direction. The locking member and the fastening portion may be integrally formed. In this case, the locking member may comprise a single or integral component, in which the fastening portion is a first section and the locking structure or element is a second section integrally formed with the first section.

[0040] The elastically movable or elastically deformable fastening element may provide a type of snap-fit ​​for snap-fitting the drug container into the container-receiving space when the fastening member reaches its final assembled configuration. In some examples, the housing component includes a recess, e.g. a through recess in the housing side wall, that overlaps or aligns with the fastening element when the fastening member reaches its final assembled configuration on the housing component, i.e. when the fastening portion reaches its final assembled configuration relative to the counter fastening portion.

[0041] The fastening elements of the fastening structure may not be aligned or engaged with the recesses or through-openings provided in the housing side wall, unless the fastening portion is yet in a final assembled configuration relative to the counter-fastening portion, in which pre-assembled configuration the fastening structure may be substantially prevented from extending, for example in a radially inward direction, into the container receiving space.

[0042] It may only be when the final assembled configuration is reached that the first fastening element of the fastening structure is aligned or overlapped with a complementary shaped recess or through opening in the housing side wall. The fastening member may then penetrate or enter the through opening in the housing side wall to engage a medicament container located within the container receiving space. In this case, upon reaching the final assembled configuration, the fastening member may elastically relax to an initial or natural configuration in which the fastening element extends into the container receiving space, thereby engaging a medicament container located therein.

[0043] According to a further example, the first fixing element is biased radially inward. The fixing element may be elastically movable radially outward against an inherent restoring force or may be elastically deformable. The fixing element may be embodied as a spring. The fixing element may include a spring arrangement, such as a leaf spring, which has a tendency to deform or move radially inward with respect to the annular shape of the fastener. In this way, the radially inwardly biased first fixing element may provide a kind of self-locking arrangement for the drug container in the container receiving space. In this case, as soon as the fixing element is moved to the final assembly configuration or position, the fixing element may be capable of deforming or moving radially inward so as to enter or extend from the outside of the housing side wall into the container receiving space and thereby mechanically engage with the drug container located in the container receiving space.

[0044] According to a further example, the first fastening element protrudes radially inward from the inner surface of the fastening part. The first fastening element may be elastically deformable or resiliently deformable radially outward, for example when the fastening member is in a pre-assembled configuration on the outer surface of the counter fastening part. When the final assembled configuration is reached, for example in which the fastening structure overlaps or aligns with the through-opening of the housing side wall, the fastening element is allowed to protrude radially inward through the corresponding through-opening or recess of the housing side wall. The fastening element may then protrude radially inward to such an extent that the fastening element not only protrudes radially inward from the inner surface of the fastening part, but also protrudes radially inward from the inner surface of the housing side wall surrounding the container receiving space.

[0045] In this manner, the fixing element, or at least a portion thereof, may protrude radially inwardly from the exterior of the housing side wall into the container-receiving space, thereby mechanically interacting with the medicament container located within the container-receiving space.

[0046] According to a further example, the first fixation element comprises a snap element having a longitudinally extending tongue, the tongue may extend longitudinally distally from the fastening portion, and the tongue, in particular a distal free end located distally of the tongue, may project radially inwardly from the annular shape of the fastening portion.

[0047] In this manner, the inside of the fastener portion may engage the exterior surface of the housing sidewall while the fastening element projects radially inward into the container receiving space. The first fastening element may include a substantially straight or elongated shape extending at an angle to the longitudinal direction. When properly assembled to the housing component, the first fastening element may extend radially inward toward the distal end of the housing component.

[0048] In other examples, the first fixation element may include, at least in part, a beveled or curved shape, for example to provide a well-defined retention or fixation force to the drug container within the container-receiving space.

[0049] In a further example, the first fixation element includes a snap element having a longitudinally extending tongue. The tongue can extend longitudinally and radially from the fastener. In some examples, the snap element or tongue can extend distally from the fastener to engage a proximally facing counter stop surface of the medicament container.

[0050] In this manner, for example, a snap element or tongue that engages a radially recessed portion of the medicament container may be configured to prevent proximal movement of the medicament container relative to the housing component.

[0051] In some examples, the fastener may include a proximal end surface, e.g., a stop surface, facing proximally to abut or engage a complementary stop surface on the distally facing housing sidewall, thereby allowing and supporting the fastener to be mounted along a longitudinal proximal direction on the housing component until the proximal end surface of the fastener engages a complementary shaped distal stop surface of the housing component or housing sidewall. A distally extending snap element or tongue of the fastener may then longitudinally engage a proximally facing counter stop surface of the medicament container, e.g., at or near the transition from the radially wider head to the radially narrower neck of the medicament container.

[0052] In this way, the medicament container can be secured against proximal movement by longitudinal abutment between a proximally facing counter stop surface and a distally facing or distally projecting snap element or tongue of the securing element. Upon longitudinal engagement with the medicament container, the securing element, e.g. molded or integrally formed with the fastening part or secured to the fastening part at least in the longitudinal direction, can transmit a corresponding proximal force effect to the fastening part, which in turn is in longitudinal proximal abutment with a distally facing stop surface of the medicament container.

[0053] In this way, the medicament container may be immobilized against proximal displacement relative to the housing component. By means of the fixing member, the medicament container may be mechanically locked within the container-receiving space of the housing component.

[0054] Typically, the housing component includes an insertion opening at its proximal end to allow distal longitudinal insertion of the medicament container into the container-receiving space, and the container-receiving space of the housing component may be distally surrounded by an end wall that provides a distal stop for the distal end of the medicament container.

[0055] In a further example, a double mutual fixation of the fastening member and the container in the housing component can be provided. As mentioned above, the fastening member can serve to fix the medicament container in the container receiving surface. In a further example, it is conceivable that the mutual mechanical engagement of a fastening structure of the fastening member and, for example, a recessed part of the medicament container in the container receiving space can also serve to fix the fastening member on the outer surface of the counter fastening part.

[0056] The drug container may abut longitudinally against a distal end wall of the drug container such that the drug container is prevented from moving distally relative to the drug container. The securing member is prevented from moving distally relative to the housing component when the securing member abuts longitudinally against a proximally facing counter stop surface provided on the drug container such that the securing member abuts longitudinally against a recessed portion, e.g., a neck, or a radial undercut of a portion of the drug container.

[0057] In this way, the mutual longitudinal abutment or longitudinal engagement of the first fastening member of the fastening structure and the drug container serves to lock the fastening member onto the housing component. In this way, the fastening member can be permanently and non-removably fixed to the housing component and to the drug container located therein. In this way, the fastening member and the drug container are mutually interlocked to the housing component such that, when the fastening member reaches the final assembled position, neither the fastening member nor the drug container can be removed therefrom.

[0058] According to a further example, the tongue of the first fixation element comprises a base and a head. The base and the head are separated along the longitudinal direction. The base is connected to the fastening part and the head forms a free end section of the tongue. Typically, it is mainly the head that is radially movable relative to the fastening part of the fixation member. The base of the tongue may be permanently fixed or integrally formed with the fastening part, whereas it is mainly the head that projects radially inward from the side wall of the fastening part.

[0059] The tongue may be of a fairly straight elongated shape and may extend radially inwards at an angle from the annular side wall of the fastener. When viewed in the circumferential direction, the tongue may taper towards its free end. Thus, the tangential or circumferential width of the tongue towards or near the head may be smaller than that towards or near the base.

[0060] In other examples, the tongue may at least partially include one of a bevel section, a raised section, or an arched section. In some examples, the tongue may include an S-shaped or C-shaped shape to provide a substantially smooth radial mechanical engagement with a recessed portion of the drug container, such as with a neck of the drug container.

[0061] In some examples, the fixing member may be assembled to the housing component in a final assembly configuration before the drug container is inserted into the container receiving space. In this case, the tongue of the first fixing element may protrude radially inwardly toward the container receiving surface. When the drug container is inserted into the container receiving space, for example, longitudinally toward a distal end of the container receiving space, the distal end of the drug container may engage with the radially inwardly extending tongue and urge the tongue radially outwardly against an elastic restoring force provided by the first fixing element.

[0062] When the drug container reaches a final assembly position or configuration within the container receiving space, the tongue is able to relax to its initial, unbiased configuration, thereby engaging with the neck of the drug container to secure or immobilize the drug container relative to the housing component, at least in the longitudinal direction.

[0063] According to further examples, the first fixation element includes a distally facing stop surface for engaging a proximally facing counter stop surface of the medicament container. In some examples, the proximally facing counter stop surface of the medicament container is provided at or near a distal end of the medicament container. The proximally facing counter stop surface may be provided in a transition zone between a radially widened head that merges proximally into a radially narrowed neck.

[0064] The radially inwardly projecting first fixing element may longitudinally or axially engage with the proximally facing head stepped section when the drug container reaches its final assembled configuration. In this way, the first fixing element may provide a proximal end stop for the drug container when it reaches its final assembled position and prevent proximal movement of the drug container relative to the housing component.

[0065] According to a further example, the first fixing element includes an inwardly facing surface for engaging with an outer surface of a flap portion of the counter fixing structure of the housing. The flap portion is at least one of radially movable and deformable. The first fixing element is configured to urge the flap portion radially inwardly when the final assembly configuration is reached. In this case, the flap portion may be located radially between the first fixing element and the drug container. The flap portion may be integrally formed with the housing component. The flap portion may be made of the same material as the housing component. Typically, the flap portion may include a plastic material, for example an injection molded plastic material. Also, the housing component may include a plastic material, for example an injection molded plastic material.

[0066] The flap portion may be movably connected to the housing component, for example, by a film hinge. The flap portion may provide a mechanical damper or cushion for the drug container to prevent direct mechanical contact between the first fixing element of the fixing member and the outer surface of the drug container. In some examples, the drug container includes a glass barrel, for example a barrel made of glass. Such a barrel may be significantly susceptible to mechanical shock. In some examples, the fixing member is itself made of an injection molded plastic component. In other examples, the fixing member includes a metal or is made of a metal or metal alloy. The use of a metal fixing member is beneficial for providing a high degree of mechanical stability while keeping the geometric dimensions of the fixing member relatively small, as well as for providing a relatively high mechanical recovery or fixing force, for example, of the first fixing element.

[0067] The flap portion of the counter-fixing structure of the housing side wall may act as or provide a mechanical shock absorber, with its outwardly facing surface adapted to engage with the inwardly facing surface of the first fixing element, and only or exclusively the inwardly facing surface and / or the longitudinal end surface of the flap portion may be in direct mechanical engagement with the medicament container.

[0068] According to a further example, the first fixing element includes a side edge extending in the longitudinal direction and protruding at least partially from the inner surface of the fastening part to engage with a recess of a counter-fixing structure on the outer surface of the housing side wall. Furthermore, the side edge of the fixing element may provide a rotational interlock between the fixing member and the housing component. The recessed counter-fixing structure on the outer surface of the housing side wall may include a through opening through which the first fixing element may extend in the radial direction. In such a configuration, the side edge of the first fixing element may be located between the complementary shaped side edges of the counter-fixing structure when viewed in the circumferential or tangential direction.

[0069] Typically, the inner periphery of the counter-fixing structure, e.g. the circumferential or tangential distance between the edges of the counter-fixing structure of a housing side wall, is greater than or equal to the outer circumferential distance between the opposing side edges of the longitudinally extending fixing element. Thus, the fixing element can engage the counter-fixing structure and thereby extend into and / or through the recessed counter-fixing structure, thereby providing or establishing a rotational interlock between the fixing member and the housing component.

[0070] According to a further example, the fixing structure further comprises a second fixing element and / or a third fixing element located circumferentially offset from the first fixing element, extending into the container receiving space and configured to mechanically engage a drug container in the container receiving space. Typically, the first fixing element and the second fixing element are somewhat or expediently identical. The same may be true for the optional third fixing element.

[0071] The first, second and / or third locking elements may be equidistantly spaced apart along the circumferential direction of the fastening part. In the first and second locking elements, the first and second locking elements may be located diametrically opposite each other. If the locking elements are provided therein, they may be arranged at an angular distance of 120° from each other. If the locking member includes two or more locking elements, the housing component also includes a corresponding number of matching recesses of the counter locking structure, e.g. a corresponding number of recesses or through-openings in the housing side wall, to engage with the corresponding locking elements.

[0072] By providing at least a second and / or a third locking element, a double or even triple mechanical locking can be provided between the locking member, the housing component, and the drug container located within the housing component. By increasing the number of locking members, redundant locking or interlocking configurations can be provided for retaining and / or securing the drug container within the container-receiving space.

[0073] According to a further aspect, the present disclosure relates to a cartridge assembly for a drug delivery device, in particular for an injection device such as a hand-held pen injector. The cartridge assembly includes a cartridge. The cartridge includes a tubular barrel containing a medicament. The cartridge, in particular the tubular barrel, includes a radially recessed neck. Typically, the cartridge includes a stopper by which the cartridge can be sealed towards a proximal end. The stopper is movably disposed within the barrel for expelling the medicament through a discharge end of the barrel. Typically, the discharge end is provided at a distal end of the barrel. The proximal end of the barrel is sealed by a movable stopper.

[0074] The cartridge assembly further comprises a housing component of the drug delivery device. The housing component may be embodied as a cartridge holder. Typically, the housing component is configured and shaped to receive or house the cartridge. The housing component comprises a housing sidewall. The housing sidewall encloses a longitudinally extending cartridge-receiving space. The housing sidewall is sized to receive the cartridge. Typically, the cartridge-receiving space is sized to receive the entire cartridge.

[0075] The housing component further includes a counter fastening portion provided on an outer surface of the housing side wall. The cartridge assembly further includes a fastening member as described above. The fastening portion of the fastening member is mechanically engageable with the counter fastening portion of the housing component. When the fastening member engages with the counter fastening portion, a first fastening element of the fastening structure of the fastening member extends into the container receiving surface and mechanically engages with the neck of the cartridge.

[0076] Typically, the fastening member is attachable or connectable to the outer surface of the housing side wall by a fastener. A first fastening element provides a mechanical interaction between the fastening member and a cartridge located in the container receiving space. In some examples, the fastening member projects radially inward into the container receiving space, thereby positively engaging with a radially recessed neck of the cartridge. In this way, the cartridge can be fixed and / or secured in the container receiving space at least in the longitudinal direction.

[0077] Since the cartridge assembly comprises the fixing member as described above, all the features, effects and advantages described above in relation to the fixing member equally apply to the cartridge assembly and vice versa.

[0078] It should be noted that the cartridges described herein are particular examples of medicament containers filled with a medicament, e.g., a liquid medicament, and in this regard, each reference to a cartridge or cartridge receiving space is synonymous with the medicament container or container receiving space referred to herein.

[0079] According to a further example, the housing side wall of the housing component includes a counter-fixing structure. The counter-fixing structure includes a first through-opening extending through the housing side wall. The first through-opening is sized to receive the first fixing element radially into or through the first through-opening. In this way, the fixing element or at least a part thereof can pass through the housing side wall. The fixing element or at least a part thereof can extend from the outside of the housing side wall through the housing side wall into the inside of the container receiving space. Typically, when embodied as a snap element with a tongue, the free end of the tongue extends through the through-opening and is positioned in the container receiving space so as to mechanically engage with a radially recessed portion of the medicament container, for example a portion of a cartridge. The first fixing element extending radially through the first through-opening can also provide a longitudinal and / or rotational interlock between the fixing member and the housing component. The longitudinally extending side edges or opposite longitudinal side edges of the first fixing element may be located between the respective side edges of the through opening, thereby preventing rotational movement of the fixing member relative to the housing component when the first fixing element engages with the first through opening.

[0080] In further examples, multiple through openings may be provided along the circumference of the housing side wall. The number and size of the individual through openings may be provided depending on the number and shape or size of the fastening elements of the fastening member. In some examples where the fastening member includes a first fastening element and a second fastening element, the housing component also includes a counter fastening structure having a first through opening and a second through opening. The size and position of the first through opening and the second through opening relative to each other correspond to the size and position or orientation of the first fastening element and the second fastening element relative to each other.

[0081] In some examples, the counter-fixing structure is provided at or near the neck of the housing component. The counter-fixing structure may be provided at or near the distal end of the housing component, which may further comprise a needle connector. The needle connector may include a threaded interface for releasably fastening the needle assembly to the housing component.

[0082] According to a further example, the housing side wall includes a counter-fixing structure with a first flap part that is radially movable or deformable relative to the housing side wall. The first flap part includes an outer surface for engaging with a first fixing element of the fixing structure of the fixing member. The first flap part further includes an inner surface for engaging with the neck of the cartridge. Typically, the first flap part serves as a mechanical shock absorber and / or as a sandwich element located between the outer surface of the medicament container and the inner surface of the first fixing element of the fixing structure of the fixing member. In this way, direct mechanical contact between the first fixing element and the outer surface of the medicament container can be avoided. This makes it possible to embody the fixing member as a metallic component that may otherwise have a certain possibility of compromising the integrity of the medicament container.

[0083] The first flap portion may be integrally attached to and / or formed integrally with the housing side wall. The first flap portion may be rotatable relative to the side wall along a pivot axis extending perpendicular to the longitudinal direction. The pivot axis may be integral to or located within the housing side wall. The flap portion may be rectangular. Only one side edge of the rectangular flap portion may be connected with the housing side wall. A further side edge of the flap portion may be separated from the side wall by a U-shaped slit.

[0084] According to a further example, the counter-fastening of the housing component comprises a tubular side wall having an outer sliding surface which allows or supports at least one of a longitudinal and circumferential sliding or gliding movement of the fastening part of the fastening member relative to the housing side wall, the outer sliding surface allowing a fairly smooth and easy sliding or gliding movement of the fastening member, for example for moving the fastening member from a pre-assembled configuration in which its fastening part is not yet engaged with the counter-fastening part of the housing side wall to a final assembled configuration in which the fastening part of the fastening member engages with the counter-fastening part of the housing side wall.

[0085] Furthermore, in the pre-assembled configuration, the fixing structure and thus the first fixing element are not yet engaged with the counter fixing structure and / or the medicament container located in the container-receiving space, and it is only when the fixing member is moved into the final assembled configuration or position that the fixing structure and thus the first fixing element thereof engages with the counter fixing structure and / or the medicament container in order to fix the medicament container in the container-receiving space at least in the longitudinal direction.

[0086] According to a further example, the fixing member comprises a proximal end face or a proximally facing end face configured to abut longitudinally with a distally facing stop surface of the housing side wall. In this way, a range of assembly movements of the fixing member directed towards the proximal direction can be defined. Furthermore, the final assembly configuration or final assembly position of the fixing member, and in particular of its fastening part, relative to the counter fastening part can be defined by mutual longitudinal abutment of the proximally facing end face of the fixing member and the distally facing stop surface of the housing side wall.

[0087] The distally facing stop surface of the housing side wall may be provided by a radial step, for example by a flange portion. In this way, when the proximal end surface of the fixing member engages with the distally facing stop surface of the housing side wall, the fixing member is prevented from further sliding proximally relative to the housing side wall. This is particularly useful for providing a proximal stop of the fixing member. The fixing structure of the fixing member may further provide a distally facing stop for engaging with a radially recessed portion of the medicament container. In this case, a proximally facing counter stop surface of the medicament container, for example provided at the head of the medicament container, may abut longitudinally with a third fixing element and thus with a distally facing stop surface of the fixing structure.

[0088] In this way, the proximal force effect ultimately acting on the medicament container, for example when attempting to remove the medicament container from the housing component, is transferred to a corresponding proximal force effect present on the fixing member. The fixing member is further secured against further proximal displacement relative to the housing side wall by its proximally facing edge or stop surface which engages with a distally facing stop surface of the housing side wall. In this way, when the fixing member reaches its final assembled configuration and the fixing element of the fixing structure engages the radially recessed portion of the medicament container, proximal removal of the medicament container from the cartridge receiving space can be substantially blocked and prevented.

[0089] According to a further example, the radially recessed portion of the cartridge or medicament container is defined in the distal direction by a radially widened head. The head includes a proximally facing counter stop surface for longitudinally abutting at least one of the first fixing element and the counter fixing structure. In some examples, when the counter fixing structure of the housing side wall comprises a first flap portion, the flap portion may include a distally facing stop surface for engaging with the proximally facing counter stop surface of the head of the cartridge. In this case, the fixing member, in particular the first fixing element thereof, serves to bias the flap portion radially inward, i.e. towards the radially recessed portion of the cartridge, thereby forcing the distally facing stop surface of the flap portion to engage with the proximally facing counter stop surface of the head of the cartridge.

[0090] In a further example where the counter fixing structure on the housing side wall does not have a movable flap portion and includes a through opening for receiving the first fixing element, it may be the distally facing free end of the first fixing element that protrudes radially inwardly that abuts or engages longitudinally with a proximally facing counter stop surface of the head of the cartridge to prevent proximal movement or removal of the cartridge relative to the container receiving space or housing portion.

[0091] According to a further aspect, the present disclosure also relates to a method of assembling a cartridge assembly of a drug delivery device, comprising inserting a cartridge into a cartridge receiving space of a housing component of the cartridge assembly, after which a fixing member is placed in a final assembly position on a counter fastening portion of a housing side wall of the housing component, and a first fixing element of the fixing member mechanically engages with a neck of the cartridge.

[0092] Typically, the method is carried out or performed by utilizing the cartridge assembly as described above and by utilizing the fixing member as described above. In this regard, all features, effects, and advantages described above apply equally to the method of assembling the cartridge assembly and vice versa.

[0093] Typically, the mechanical engagement of the first locking element of the locking structure with the neck of the cartridge is obtained automatically by moving or transferring the locking member from a pre-assembly position or configuration to a final assembly configuration or position. This final stage of assembly can be performed by, for example, a longitudinal and / or circumferential sliding movement of the locking member relative to the housing side wall of the housing component. For this purpose, the fastening portion of the locking member and the complementary shaped counter-fastening portion provided on the outer surface of the housing side wall can comprise complementary shaped sliding and counter-sliding surfaces.

[0094] The currently proposed method of assembling a cartridge assembly provides for fixing a cartridge or drug container in a receptacle or cartridge receiving space of a housing component, typically embodied as a cartridge holder. In this case, it is particularly advantageous that the fixing element does not protrude inwardly into the receptacle receiving space in the pre-assembled position. As long as the fixing element is in the pre-assembled configuration, the first fixing element may be located on the outer surface of the housing side wall. The first fixing element may be pretensioned or pre-biased radially inwardly with respect to the outer surface of the housing side wall. It is only after the insertion of the drug container into the receptacle receiving space that the fixing element is moved to the final assembled configuration, thereby aligning the first fixing element with a through-opening or a counter-fixing structure provided on or in the housing side wall of the housing component. The elastically movable or elastically deformable fixing element may then be able to move radially inwardly through the through-opening of the housing side wall into a radially recessed portion of the cartridge in order to fix the cartridge in the longitudinal direction.

[0095] In this manner, the radially inwardly projecting portions of the cartridge assembly are provided after insertion of the cartridge into the container or cartridge receiving space, and during or for insertion of the cartridge into the cartridge receiving space, the inside of the housing side wall surrounding the container or cartridge receiving space need not have radially inwardly extending protrusions that may compromise the integrity of the distal discharge end of the medicament container.

[0096] In a further example, it is conceivable to place the fixing member in a final assembly configuration before the cartridge is inserted into the cartridge or container receiving space. During the insertion operation, during the final assembly process, the distal end of the cartridge or medicament container may at least temporarily bias the radially inwardly protruding first fixing element in a radially outward direction. Upon reaching the final assembly position, i.e., upon reaching a distal end position within the container receiving space, the radially tapered or radially recessed portion of the cartridge is aligned with the first fixing element, thereby allowing the first fixing element to snap or latch radially inwardly into longitudinal engagement with a proximally facing counter stop surface provided on the radially widened head of the cartridge or medicament container.

[0097] According to another aspect, the present disclosure also relates to a drug delivery device embodied 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 typically connectable to the cartridge assembly described above. The drug delivery device typically comprises a drive mechanism, for example including a piston rod for exerting an ejection force on a piston located in a tubular barrel of the cartridge, the cartridge being typically provided and / or fixed in a housing component or cartridge holder of the cartridge assembly. Typically, the cartridge assembly is configured to be removably or non-removably fixed to the body of the drug delivery device.

[0098] The drug delivery device typically includes the cartridge assembly described above. In this regard, all the features, effects and advantages described above with respect to the cartridge assembly apply equally to the drug delivery device.

[0099] In some examples of drug delivery devices or cartridge assemblies, the securing member may be mechanically coded to the cartridge or type of cartridge. Thus, one of a number of available different configurations of the securing member may be selected depending on the size of the cartridge and / or depending on the type of medicament contained within the cartridge. Similarly, the counter fastening portion of the housing side wall and / or the counter securing structure may be coded for a particular type of cartridge or medicament.

[0100] In another example, the fixing member may be universally usable with a wide variety of different types of cartridges, different medicaments in such cartridges, and different types of housing components, such as cartridge holders. In this case, the pharmaceutical manufacturer can ensure that the correct cartridge is always inserted into the appropriate, matching cartridge holder. By utilizing the fixing members described herein, it can be ensured that the cartridge is permanently and irremovably fixed in the cartridge receiving space of the cartridge holder or housing component. Thus, a cartridge assembly may be commercially available that includes a cartridge, a housing component, and a fixing member that irremovably attaches the cartridge in the cartridge holder or housing component. An end user or patient is effectively prevented from removing or ejecting the cartridge from the cartridge holder or housing component.

[0101] In other examples, the differently configured fixing members may be distinguished from each other by at least one of their fastenings and their fixing structures. For example, a first fixing member may be configured to engage only with a first type of cartridge. A first housing component may be mechanically coded to exclusively connect with only one of several available bodies or drive mechanisms of a drug delivery device. Thus, differently coded housing components or differently coded cartridge holders may be distinguished from each other by the shape and / or geometry of the cartridge receiving space to avoid unintended cross-use of cartridges not intended for use with a particular drive mechanism or body of an injection device.

[0102] A cartridge assembly including a cartridge, a cartridge holder, and a fixing member that permanently fixes or can fix the cartridge in the cartridge holder can be manufactured and assembled by a pharmaceutical manufacturer. Such a cartridge assembly can be commercially available for a reusable drug delivery device. The cartridge holder of the cartridge assembly and the body of the drug delivery device can be mechanically coded to prevent unintended cross-use, i.e., to prevent the use of a first type of body and / or drive mechanism with a second type of cartridge or cartridge holder that is not intended to be used with this particular body or drive mechanism. In effect, providing a cartridge assembly with a fixed cartridge in the drug delivery device can increase patient safety and effectively prevent misuse of the drug delivery device.

[0103] Generally, the scope of the present disclosure is defined by the content of the claims. The infusion 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.

[0104] In the present context, the term "distal" or "distal end" refers to the end of the injection device that points towards the injection site of a person or animal. 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.

[0105] As used herein, the terms "drug" or "medicament" are used interchangeably 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 its broadest sense, is a chemical structure that exerts a biological effect on humans or animals. In pharmacology, drugs or agents are used to treat, cure, prevent, or diagnose disease, or to otherwise enhance physical or mental comfort. Drugs or agents may be used for a limited period of time or periodically for chronic conditions.

[0106] As described below, a drug or agent 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.

[0107] The drug or agent may be contained in a primary package or "drug container" adapted for use with the drug delivery device. The drug container may be, for example, a cartridge, a syringe, a 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 examples, 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 examples, 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 examples, 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 examples, the two chambers of the dual-chamber cartridge may be configured to allow mixing between the two or more components before and / or during ejection into the human or animal body. For example, the two chambers may be configured such that they are in fluid communication with one another (e.g., via a conduit between the two chambers) to allow mixing of the two components when desired by a user prior to ejection. Alternatively, or in addition, the two chambers may be configured to allow mixing of the components as they are ejected into the human or animal body.

[0108] The drugs or agents contained in the drug delivery devices 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 or complications related to diabetes, such as diabetic retinopathy, thromboembolism, such as deep vein thromboembolism or pulmonary thromboembolism. Further examples of disorders are 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, for example, but not limited to, main groups 12 (antidiabetic drugs) or 86 (oncology drugs), and the Merck Index, 15th edition.

[0109] 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 is formally derivable from the structure of a naturally occurring peptide, e.g., the structure of human insulin, by deletion and / or replacement of at least one amino acid residue occurring in the naturally occurring peptide and / or by addition of at least one amino acid residue. The added and / or substituted amino acid residues can be either coded 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, e.g., 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 of the amino acids occurring in the naturally occurring peptide may be deleted and / or replaced with other amino acids, including non-coded amino acids, or amino acids, including non-coded amino acids, may be added to the naturally occurring peptide.

[0110] 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.

[0111] 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.

[0112] Examples of GLP-1, GLP-1 analogues and GLP-1 receptor agonists are e.g. lixisenatide (Lyxumia®), exenatide (exendin-4, Byetta®, Bydureon®, a 39 amino acid peptide produced by the salivary glands of the Gila monster), liraglutide (Victoza®), semaglutide, taspoglutide, albiglutide (Syncria®), dulaglutide (Trulicity®), rExendin-4, CJC-1134-PC, PB-1023, TTP-054, langrenatide / HM-11260C (efpegrenatide), HM-15211, CM-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.

[0113] An example of an oligonucleotide is, for example, mipomersen sodium (Kynamro®), a cholesterol-lowering antisense therapeutic for the treatment of familial hypercholesterolemia, or RG012 for the treatment of Alport Syndrome.

[0114] Examples of DPP4 inhibitors are linagliptin, vildagliptin, sitagliptin, denagliptin, saxagliptin, berberine.

[0115] Examples of hormones include pituitary or hypothalamic hormones or regulatory active peptides such as gonadotropins (follitropin, lutropin, chorion gonadotropin, menotropin), somatropin (somatropin), desmopressin, terlipressin, gonadorelin, triptorelin, leuprorelin, buserelin, nafarelin and goserelin, and their antagonists.

[0116] Examples of polysaccharides include glycosaminoglycans, hyaluronic acid, heparin, low molecular weight heparin, or very low molecular weight heparin, or derivatives thereof, or sulfated forms of the above polysaccharides, such as polysulfated forms, and / or pharma- ceutically acceptable salts thereof.An example of a pharma-ceutically 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.

[0117] 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. An antibody can 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, an antibody has effector functions and can fix complement. In some embodiments, an antibody has reduced or no binding ability to Fc receptors. For example, an antibody can 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 (TBTIs) and / or dual variable region antibody-like binding proteins with crossover binding region orientation (CODV).

[0118] The term "fragment" or "antibody fragment" refers to a polypeptide derived from an antibody polypeptide molecule (e.g., an antibody heavy and / or light chain polypeptide) 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.

[0119] The term "complementarity determining region" or "CDR" refers to short polypeptide sequences within the variable regions of both the 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 the heavy and light chain polypeptides that are not CDR sequences and that 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 can be directly involved in antigen binding or can affect the ability of one or more amino acids in the CDR to interact with the antigen.

[0120] 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).

[0121] Pharmaceutically acceptable salts of any of the APIs described herein are contemplated for use with the drug or medicament in the drug delivery device. Pharmaceutically acceptable salts include, for example, acid addition salts and base salts.

[0122] It will be understood by those skilled in the art that modifications (addition 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.

[0123] An exemplary drug delivery device may include a needle-based injection system 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 (partial or full discharge) container systems. The container may be a replaceable container or may be an integrated non-replaceable container.

[0124] As further described in ISO11608-1:2014(E), a multi-dose container system may include a needle-based injection device with replaceable containers. In such systems, each container holds multiple doses and the size may be fixed or variable (pre-set by the user). Other multi-dose container systems may include a needle-based injection device integrated with a non-replaceable container. In such systems, each container holds multiple doses and the size may be fixed or variable (pre-set by the user).

[0125] As further described in ISO11608-1:2014(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 expels the entire deliverable amount (full expulsion). In a further example, each container holds a single dose, which expels a portion of the deliverable amount (partial expulsion). As also described in ISO11608-1:2014(E), the single dose container system may include a needle-based injection device with an integrated replaceable container. In one example of such a system, each container holds a single dose, which expels the entire deliverable amount (full expulsion). In a further example, each container holds a single dose, which expels a portion of the deliverable amount (partial expulsion).

[0126] 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.

[0127] A number of examples of data logging devices for monitoring infusion device usage and corresponding infusion devices are described in more detail below with reference to the drawings. [Brief description of the drawings]

[0128] [Figure 1] 1 illustrates a schematic diagram of an example of a drug delivery device. [Diagram 2] 1 shows a cartridge holder and a cartridge for insertion into the cartridge holder. [Diagram 3] 1 shows the cartridge assembly before the fixing member is attached to the cartridge holder. [Figure 4] FIG. [Diagram 5] FIG. 13 is an enlarged view of the fixing member attached to the cartridge holder in the final assembled configuration. [Figure 6]1 is a side view of a cartridge assembly having a fixing member attached to a cartridge holder; FIG. [Figure 7] 13 shows a further example of a securing member in a pre-assembled configuration attached to a cartridge holder prior to insertion of a cartridge. [Figure 8] 8 shows the configuration of FIG. 7 after the cartridge has been inserted into the cartridge receiving space. [Figure 9] 9 shows the cartridge assembly of FIGS. 7 and 8 in a final assembled configuration. [Figure 10] 1 illustrates a longitudinal cross-sectional view of the cartridge assembly in a final assembled configuration. [Figure 11] FIG. 11 is an enlarged view of the distal end of the cartridge assembly of FIG. [Figure 12] FIG. 12 is a further perspective view of the distal end of the cartridge assembly according to FIG. 11. [Figure 13] 13 illustrates a further example of a cartridge assembly prior to insertion of a cartridge into a cartridge holder. [Figure 14] 13 shows a fixing member attached to a cartridge holder in a pre-assembled configuration. [Figure 15] FIG. 2 is a cross-sectional view of the distal end of the cartridge assembly. [Figure 16] 1 is a flow chart of a method of assembling a cartridge assembly. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0129] FIG. 1 shows an example of a drug delivery device 1 embodied as a pen injector. The drug delivery device 1 comprises a number of housing components. In particular, the drug delivery device 1 comprises a tubular housing component 30 embodied as a cartridge holder 31 sized 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 dosing 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 embodied as a cartridge 10. Typically, the drive mechanism 7 comprises a piston rod 80, for example with a pressure piece 81 at its distal end. The pressure piece 81 is configured to abut in the longitudinal direction (z) against a proximal end face of a piston 25 slidably arranged in the barrel 11 of the cartridge 10. The piston 25 is shown for example in FIG. 10.

[0130] Barrel 11, which may be of a vitreous material such as glass, includes a sidewall 12 having a substantially tubular main portion 14. A piston 25 is slidably movable along main portion 14. Main portion 14 merges into a narrowing shoulder 15 toward a discharge end 27, which in turn merges into a radially tapered neck 16. Neck 16 terminates in a head 18, which may include, at least on its outer surface, a slightly radially wider cross-section compared to neck 16.

[0131] The drug delivery device 1 further comprises a protective cap 4 configured to cover the discharge end 27 of the drug delivery device 1. Typically, the housing component 30 is embodied 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 a needle assembly, e.g. a double ended injection needle, to inject a dose of the liquid medicament 26 into biological tissue. The distal end 43 may comprise a cylindrical portion 38. The cylindrical portion 38 may comprise or comprise a needle connector 36 having a threaded section 49. The threaded section 49 is one example for supporting a threaded connection with a complementarily shaped needle hub comprising the injection needle.

[0132] The distal end 43 of the cartridge holder 31 further includes an aperture 50 for receiving a proximal or proximally extending portion of a double-ended 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 include a pierceable septum 21, which is secured to the distal head 18 of the cartridge by a septum retainer 22. The septum retainer 22 may include a beaded cap 23 made of a flexible material such as aluminum or plastic.

[0133] The septum retainer 22 includes an aperture 24 that aligns with the aperture 50 when the cartridge 10 is received within the cartridge holder 31. The interior of the cartridge holder 31 defines a cartridge-receiving space 33 that is substantially occupied by the cartridge 10 when assembled within the cartridge holder 31. The cartridge holder 31, and in particular the housing side wall 32, includes a main portion 47 that includes a somewhat cylindrical shape. The main portion 47 is adapted to receive the main portion 14 of the barrel 11 of the cartridge 10.

[0134] The cartridge holder 31 includes a proximal end 44 that may include an insert 52 sized and configured for insertion into a receptacle 82 provided at the distal end of the body 6. The insert 52 is bounded in the distal direction 2 by a flange portion 55. When the cartridge holder 31 is attached to the body 6, the flange portion 55 may abut longitudinally against a distal end face of a side wall of the receptacle 82.

[0135] The receptacle 82 may be provided on its inner side with a counter-fastening structure 83, e.g. in the form of a radial projection or a radial recess, for engaging with a complementary shaped fastening element 53 provided on the outer surface of the insert 52. In this way, the proximal end 44 of the cartridge holder 31 may be fixedly attached to the body 6.

[0136] Optionally, the proximal end 44 of the cartridge holder 31 includes a coding element 54 by which the cartridge assembly 150 can be mechanically coded and distinguished from another cartridge assembly 150, for example, comprising a different type of cartridge 10 or comprising a cartridge containing a different medicament 26. The coding element 54 or coding feature may be complementary in shape or arrangement to a counter-coding element 84 provided on or in the body 6. A mismatched pairing of the coding element 54 and the counter-coding element 84 may prevent interlocking of the cartridge holder 31 to the body 6.

[0137] Mutual fastening and fixation of the cartridge holder 31 to the main body 6 can be provided and made possible only when the coding element 54 of the cartridge holder 31 matches in size, shape and position with a corresponding counter coding element 84 provided on or within the main body 6.

[0138] In one aspect, the present disclosure relates to a cartridge assembly 150 that includes a housing component 30 embodied, for example, as a cartridge holder 31 , and further includes a cartridge 10 and a securing member 100 .

[0139] The fixing member 100 shown in FIG. 4 includes a fastening portion 110 and a fixing structure 120. The fastening portion 110 is configured to fasten to a complementary shaped counter fastening portion 60 provided on the outer surface 34 of the housing side wall 32 of the housing component 30. As is clear from FIGS. 1 to 6, the counter fastening portion 60 is provided on the neck portion 46 of the cartridge holder 31. The counter fastening portion 60 includes a tubular side wall portion 62. The outer surface 63 of the side wall portion 62 includes a sliding surface 67 that allows a fairly smooth sliding or gliding of the complementary shaped inner surface 113 of the fastening portion 110 of the fixing member 100 during the process of assembling the fixing member 100 on the cartridge holder 31. In this respect, the inner surface 113 of the side wall 111 of the body 101 of the fixing member 100 may also provide a sliding surface 117 of a shape complementary to the sliding surface 67 of the counter fastening portion 60 of the cartridge holder 31.

[0140] In this illustrated example, the fastening structure 120 includes a first fastening element 121, a second fastening element 122, and a third fastening element 123. The fastening elements 121, 122, 123 are equidistantly spaced apart along the circumference of the fastening member 100. The body 101 of the fastening member 100 is somewhat tubular. The fastening portion 110 includes a tubular sidewall 111 that forms a fastening ring 112. The sidewall 111 is annular and / or tubular. The fastening ring 112 includes a closed ring structure. In other examples (not shown), the fastening ring can include an open or interrupted annular structure, which can increase the resiliency of the fastening member.

[0141] In some examples, the fixing member 100 is made of sheet metal. The fixing member 100 may be integrally formed. The fixing member 100 may include a single piece. Each of the individual fixing elements 121, 122, 123 includes or comprises a radially elastically deformable snap element 125. The snap elements 125, and therefore the fixing elements 121, 122, 123, each include a longitudinally extending tongue 126 that projects radially inward from the side wall 111 of the body 101 of the fixing member 100. Each of the tongues 126 includes a base 134, via which the tongues 126 are connected to the annular fastener 110. When properly assembled to the housing component 30, the tongues 126 extend or project in the distal direction 2 from the fastener 110.

[0142] Thus, the free end section provided by the head 135 forming the opposite end of the bottom 134 of the tongue 126 is located closer to the distal end 42 of the cartridge holder 31 than the bottom 134 .

[0143] The bottom 134 may be longitudinally adjacent to the fastener 110. The outer surface of the bottom 134 may be flush with the outer surface 114 of the fastener 110. In some examples, it is even conceivable that the tongue 126 includes an S-shaped configuration. In this case, the bottom 134 may protrude radially outward from the outer surface 114 of the fastener 110. Thus, the middle section of the tongue 126 and / or the head 135 located on the opposite side may protrude radially inward. The S-shaped structure of the tongue 126 may provide an increased biasing effect and may be beneficial in providing a resilient clamping effect when attached to the outer surface 34 of the cartridge holder 31.

[0144] In some instances, the tongue 126 has a somewhat rectangular or tapered shape, as shown in Figure 4. The base 134 is integrally formed with the body 101 of the fixation member 100, while the opposing longitudinal side edges 129, 131 are separated from the sidewall 111 of the fixation member 100 by longitudinal slits 128, 132.

[0145] In this case, the side wall 111 includes a longitudinally or axially extending side edge 127 adjacent a slit 128. The opposite side of the slit 128 is closed by a longitudinally extending side edge 129 of the tongue 126. The opposite peripheral end of the tongue 126 is defined by a side edge 131 adjacent a slit 132. The slit 132 separates a side edge 133 of the side wall 111 from the side edge 131 of the tongue 126. In this way, due to the inherent elasticity of the material of the body 101 of the fixing member 100, at least the free end of the tongue 126, and therefore the head 135, is radially deformable and can be biased or moved radially outward against a restoring force.

[0146] 4, the head 135 of the tongue 126 projects radially inwardly from the inner surface 113 of the sidewall 111.

[0147] The fixing member 100 is provided as a separate part suitable for mounting and / or fixing to the cartridge holder 31, for example after insertion of the cartridge 10 into the cartridge receiving space 33. As shown in more detail in Figures 1 to 6, the housing side wall 32 of the cartridge holder comprises a counter-fixing structure 70. In the example of Figures 1 to 12, the counter-fixing structure 70 comprises a through-opening 72 extending through the housing side wall 32. The through-opening 72 forms a fixing recess 71 for receiving a fixing element 121 of a fixing structure 120 of the fixing member 100 when the fixing member 100 reaches its final assembled configuration.

[0148] 1-12, the first locking element 121 fits into the locking recess 71 and extends through the through opening 72 into the container receiving space 33. As shown particularly in FIG. 11, when the final assembled configuration is reached, the first locking element 121 engages the radially recessed portion 16 of the cartridge 10. In particular, a distally facing stop surface 130 of the tongue 126 longitudinally abuts a proximally facing counter stop surface 28 provided, for example, at or on the radially widened head 18 of the cartridge 10.

[0149] As shown in FIG. 11 , the counter stop surface 28 may be covered or provided by the septum retainer 22. In the final assembled configuration, the fastening portion 110 of the fixation element 100 abuts longitudinally with a distally facing stop surface 44 provided on the outer surface 34 of the side wall housing 32 of the cartridge holder 31. The stop surface 44 is provided at or on a shoulder 45 of the housing side wall 32. The stop surface 44 provides a proximal stop for the fastening portion 110, for example, when the fixation member 100 is mounted proximally 3 on the cartridge holder 31. In this case, the proximal end surface 116 of the side wall 111 of the fastening portion 110 abuts longitudinally and therefore proximally with the distally facing stop surface 44 provided on the cartridge holder 31, thereby limiting the proximal assembly movement of the fixation member 100 relative to the cartridge holder 31.

[0150] When in the final assembled configuration shown in FIG. 11 , the stop surface 130 of the first fixing element 121 abuts longitudinally against the proximally facing counter stop surface 28 of the cartridge 10, so that any attempt to remove the cartridge 10 in the proximal direction 3 will transmit the respective forces to the fixing element 121, resulting in the side wall 111 abutting longitudinally against the stop surface 44 of the cartridge holder 31, such that it cannot be moved in the proximal direction 3.

[0151] As further shown in FIG. 11 , the counter fastening portion 60 of the cartridge holder 10 is distally surrounded by a radially stepped portion 39 adjacent the connectorless portion 37 of the needle connector 36 at the distal end 42 of the cartridge holder 31. In the final assembled configuration, the distal end face 115 of the side wall 111 of the fixing member 100 is aligned with the stepped portion 39. In this way, substantially the entire inner surface 113 of the side wall 111 of the fixing member 100 can be in mechanical contact with the complementarily shaped outer surface 63 of the counter fastening portion 60. In this way, a fairly robust and well-defined mechanical support for the fixing member 100 on the outer surface 34 of the housing side wall 32 can be provided.

[0152] The fixing element 121 projects radially inwardly through the through opening 72 in the housing side wall 32 and longitudinally engages the recessed neck 16 of the cartridge 10 to also provide non-releasable fixation of the fixing member 100 to the cartridge holder 31. As shown in detail in FIG. 11 , the distal end face 29 of the cartridge 10, e.g., the distal end face of the septum retainer 22, longitudinally abuts a proximally-facing portion of the end wall 57 of the distal end 42 of the cartridge holder 10.

[0153] When in the final assembled configuration, the distal end of the cartridge 10 abuts longitudinally against the proximally facing side of the end wall 57. When in the final assembled configuration, the cartridge 10 cannot be moved further in the distal direction 2 relative to the cartridge holder 31. Now, as shown in FIG. 11 , when the locking structure 120, in particular the locking element 121, abuts longitudinally against the counter stop surface 28, the cartridge 10 abuts distally against the end wall 57, so that the locking member 100 is prevented from moving in the distal direction 2 relative to the cartridge 10, and thus relative to the cartridge holder 31.

[0154] In this way, the interengagement of the fastening elements 121 with the radially recessed portion 16 of the cartridge in the container receiving space 33 serves to secure the cartridge 10 in the cartridge holder 31 and also prevents the fixing member 100 from being removed in the distal direction 2 from the cartridge holder 31. Removal of the fixing member may require a special tool to bias or move the fixing element 121 radially outwardly, thereby disengaging it from the neck 16 or head 18.

[0155] Thereafter, by forcing the head 135 of the tongue 126 radially outwardly of the counter fixing structure 70, the cartridge 10 can be removed from the cartridge holder 31 in the proximal direction 3 and / or the fixing member 100 can be removed from the cartridge holder in the distal direction 2.

[0156] In some instances, if the through opening 72 includes a shape that closely matches the shape of the fastening elements 121, 122, 123, it may be nearly impossible to insert a tool into the through opening 72 to urge any of the fastening elements 120, 121, 122, 123 radially outwardly to, for example, disengage them from the cartridge 10. This may be particularly true if the longitudinal side edges 73, 74 of the through opening 72 include a circumferential distance that is equal to or slightly greater than the circumferential distance between the side edges 129, 131 opposite the tongue 126.

[0157] Further examples of cartridge assemblies 150 may be provided in which the circumferential distance between the longitudinally extending side edges 73, 74 of the counter fixing structure 70 is generally greater than the corresponding circumferential extent of the tongues 126. Thus, the establishment of the final assembly configuration and thus the fitting of the fixing elements 121, 122, 123 into the corresponding fixing recesses 71 or through openings 72 may be facilitated. Similarly, disassembly may be possible by utilizing a tool, for example, sized to enter the through openings 72 and configured to bend or move the fixing elements 121, 122, 123 radially outward.

[0158] By terminating the fastening portion 110 or side wall 111 of the fixing member 100 in the distal direction 2 by the stepped portion 39 of the housing side wall 32, the fixing member 100 can be located completely outside the needle connector 36 or outside the connector-free portion of the housing side wall 32, thus enabling and supporting a much easier and smoother attachment of the needle assembly to the needle connector 36.

[0159] In the example cartridge assembly 150 shown in Figures 1-6, the cartridge 10 is intended to be placed in the cartridge or container receiving space 33 before the fixing member 100 is placed in the final assembled configuration shown in Figure 5. As shown in Figure 3, the fixing member 100 may be attached or placed on the outer surface 34 of the cartridge holder 31 after insertion of the cartridge 10 into the cartridge receiving space 33. Attachment of the fixing member 100 to the counter fastening portion 60 of the cartridge holder 31 may include a longitudinal sliding movement of the fixing member 100 in the proximal direction 3 relative to the cartridge holder 31.

[0160] The longitudinal sliding movement may require proper circumferential alignment of the fixing elements 121 with the counter fixing structures 70 provided on the outer surface 63 of the counter fastening part 60. When the final assembled configuration is reached, the radially inwardly extending tongues 126 of the various fixing elements 121, 122, 123 may fit into the fixing recesses 71 and thus extend through corresponding through openings 72 provided on or in the neck 46 of the cartridge holder 31.

[0161] In a pre-assembled configuration (not shown), the fixing member 100 may be placed or attached to the neck 46 of the cartridge holder 31 before or during insertion of the cartridge holder 10. In this case, the fixing member 100 may be placed in a pre-assembled configuration distally offset from the final assembled configuration as shown in FIG. 5. In such a pre-assembled configuration, the radially inwardly biased inner side of the fixing elements 121, 122, 123 may engage with the needle connector 36, in particular with the threaded section 49 or the connectorless portion 37 of the needle connector 36. In this way, the radially inwardly biased configuration of the fixing elements 121, 122, 123 may maintain the fixing member 100 in a stable pre-assembled configuration. This kind of pre-fixing to the housing component 30 is beneficial to avoid handling the fixing members separately during the assembly of, for example, the cartridge assembly 150 or the respective drug delivery device 1.

[0162] In the example of Figures 13 to 15, the fixing member 100 is shown in another pre-assembled configuration. In this case, the pre-assembled position or pre-assembled configuration of the fixing member 100 is offset circumferentially from the final assembled configuration. The fixing structure 120, and therefore the fixing element 121, is offset at an angle from the position of the counter fixing structure 170. In order to move the fixing member 100 from the pre-assembled configuration shown in Figures 13 and 14 to the final assembled configuration, it is necessary to rotate the fixing element 100 clockwise relative to the cartridge holder 31, thus along the tangential direction t indicated by the arrow in Figure 8. When the final assembled configuration is reached, the fixing element 121 engages in one of the fixing recesses 71 and provides a similar longitudinal fixation of the cartridge 10 in the cartridge receiving space 33 as described above in connection with Figures 1 to 6.

[0163] When the locking element 121 engages the counter locking structure 70, the side edges 129, 131 of the tongue 126 collide with the side edges 73, 74 of the through opening 72 when a user attempts to rotate the locking member 100 relative to the cartridge holder 31 after establishment of the final assembled configuration. In this regard, the engagement of the locking structure 120 with the counter locking structure 70 provides a rotational interlock for non-rotatably locking the locking member 100 to the cartridge holder 31.

[0164] In a further example shown in Figs. 13-15, the counter-fixing structure 170 is slightly modified compared to the counter-fixing structure 70 described above. In this case, the counter-fixing structure 170 comprises a flap portion 162 integrally formed with the side wall 32 of the cartridge holder 31. The flap portion 162 is radially deformable or bendable. The flap portion 162 may cover at least a portion of the through-opening 72 provided in the neck portion 46 of the side wall 32 of the cartridge holder 31. The flap portion 162 may be integrally attached to the side wall 32. Typically, the proximal end of the flap portion 162 may be integrally formed with the side wall 32. The opposite end of the flap portion 162, and therefore the distal end, is typically radially movable to engage with the counter stop surface 28 of the cartridge 10, as shown in Fig. 15.

[0165] In this case, the flap portion 162 includes a distally facing stop surface 165 for longitudinally engaging or abutting the proximally facing counter stop surface 28 of the cartridge 10. The flap portion 162 includes an outer surface 163 that may engage an inner surface of the fastening element 121. In this manner, when properly aligned with the counter locking structure 177, the locking structure 120, and in particular the locking element 121, serves to exert a radially inward force effect on the movable or radially deformable flap portion 162, thereby biasing the flap portion 162 radially inward.

[0166] The stop surface 165 of the flap portion 162 then engages the recessed neck 16 of the cartridge 10. Furthermore, an inner surface 164 of the flap portion 162 may be in mechanical contact with an outer surface of the barrel 11 of the cartridge 10. Typically, the flap portion 162 is made of a plastic material. The flap portion 162 may be embodied as an integral component of the cartridge holder 31, which may be embodied as an injection molded plastic component. The fixing member 100 may be embodied as a plastic or metal component. If the fixing member is embodied as a metal component, the flap portion 162 prevents direct contact between the metal part of the fixing member 100 and the cartridge 10.

[0167] 13-15, it is also contemplated that the fixing member 100 may be placed in the final assembly configuration before the cartridge 10 is inserted into the cartridge receiving space 33. In this case, the flap portion 162 may protrude radially inward from the inner surface 35 of the side wall 32 and thus into the cartridge receiving space 33. Because the flap portion 162 is made of a substantially soft or pliable material, no significant damage may occur to the cartridge 10 or the septum retainer 22 when, during cartridge assembly, the cartridge is urged in the distal direction 2 into the final assembly configuration within the cartridge receiving space 33, thereby at least temporarily urging the radially biased flap portion 162 radially outward.

[0168] Thereafter, when the cartridge 10 reaches its final assembled configuration, i.e., when the distal end face 29 of the cartridge 10 abuts the inwardly facing portion of the end wall 57, the radially widened head 18 is positioned distally from the flap portion 162, thereby allowing the flap portion 162 to be biased radially inward under the influence of the relaxing fixation element 121.

[0169] The flow chart of Figure 16 illustrates a method of assembling a cartridge assembly 150 as described herein. In a first step 200, the cartridge 10 is inserted into the cartridge receiving space 33 of the cartridge holder 31. Typically, the cartridge 10 is inserted along the longitudinal distal direction 2. The cartridge 10 is placed into the cartridge receiving space 33 through an insertion opening 48 provided in the proximal end 43 of the cartridge holder 31.

[0170] Thereafter, in step 202, the securing member 100 is attached to the cartridge holder 31. During step 202, the securing member can be positioned or moved towards a final assembly configuration in which the fastening portion 110 of the securing member 100 engages with a counter fastening portion 60 provided on the outer surface 34 of the housing side wall 32 of the cartridge holder 31. In step 200, the securing member 100 can be moved from a pre-assembly configuration in which the fastening portion 110 is already engaged with the counter fastening portion 60 to a final assembly configuration in which the securing structure 110 engages with the counter securing structure 170.

[0171] The final step of assembly is reached in step 204. Here, when the final assembled configuration is reached, the fixing element 121 is fitted into the counter fastening structure 70 and can thus extend through the through opening 72 into the cartridge receiving space 33, thereby engaging, for example, the recessed neck 16 of the cartridge 10.

[0172] In another example, the steps of inserting the cartridge 10 and attaching the fixing member 100 to the cartridge holder 31 may be reversed. The fixing member 100 may then be placed in a final assembly position on the cartridge holder 31 before the cartridge 10 is inserted into the cartridge receiving space 33. In a next step, the cartridge 10 is biased into the final assembly position in the cartridge receiving space 33, thereby at least temporarily biasing the radially inwardly biased fastening elements 121, 122, 123 radially outward. Upon reaching the final assembly configuration, the fastening elements 121, 122, 123 relax radially inwardly, thereby engaging the radially recessed neck 16 of the cartridge. [Explanation of symbols]

[0173] 1. Drug Delivery Devices 2 Distal direction 3 Proximal direction 4 Protective cap 5. Drug containers 6 Main unit 7 Driving mechanism 8 Dispensing member 9. Trigger 10 Cartridge 11 Barrel 12 Side wall 14 Main part 15 Shoulder 16 neck 18 head 20 Seal 21 Septum 22 Septum retainer 23 Beaded Cap 24 Aperture 25 Piston 26 Drugs 27 Discharge end 28 Counter stop surface 29 Distal End Face 30 Housing Components 31 Cartridge holder 32 Side wall 33 Cartridge storage space 34 Exterior 35 Inside 36 Needle Connector 37 No connector part 38 Cylindrical section 39 Stepped part 42 Distal end 43 Proximal end 44 Stop surface 45 Shoulder 46 Neck 47 Main part 48 Insertion opening 49 Threaded Section 50 Aperture 52 Insert 53 Fastening Elements 54 Coding Elements 55 Flange part 57 End Wall 60 Counter fastening part 62 Side wall 63 Exterior 67 Sliding Surface 70 Counter fixing structure 71 Fixing recess 72 Through opening 73 Side edge 74 Side edge 80 Piston rod 81 Pressure Components 82 Receptacle 83 Counter fastening structure 84 Counter Coding Elements 100 Fixed part 101 Main unit 110 Fastening part 111 Side wall 112 Fastening ring 113 Inside 114 Exterior 115 Distal end face 116 Proximal end face 117 Sliding Surface 120 Fixed structure 121 Fixed elements 122 Fixed elements 123 Fixed elements 125 Snap Elements 126 Tongue 127 Side edge 128 Slit 129 Side edge 130 Stop surface 131 Side edge 132 Slit 133 Side edge 134 Bottom 135 Head 162 Flap section 163 Exterior 164 Inside 165 Stop surface 170 Counter fixing structure

Claims

1. A fixing member (100) for fixing a drug container (5) in a housing component (30) of a drug delivery device (1), said housing component (30) including a housing side wall (32) surrounding a container receiving space (33) and extending in a longitudinal direction (z), said fixing member (100) comprising: a fastening portion (110) including an inner surface (113) of a shape complementary to an outer surface (63) of a counter-fastening portion (60) of said housing side wall (32), said inner surface (113) being sized and shaped to support at least one of a longitudinal and a circumferential fastening movement of said fastening portion (110) relative to said counter-fastening portion (60) to reach a final assembled configuration; a fixing structure (120) connected to said fastening part (110) and including a first fixing element (121), said first fixing element (121) configured to extend into said container receiving space (33) and to mechanically engage with said drug container (5) located in said container receiving space (33) when said fastening part (110) reaches said final assembled configuration on said counter fastening part (60); A fixing member (100).

2. The fixing member (100) of claim 1, wherein the fastening portion (110) comprises an annular side wall (111).

3. The fixing member (100) according to claim 1 or 2, wherein the fastening portion (110) comprises an annular fastening ring (11).

4. The fixing member (100) according to any one of the preceding claims, wherein the fastening portion (110) comprises a closed ring.

5. The fixing member (100) according to any one of claims 1 to 4, wherein the inner surface (113) comprises a sliding surface (117) configured to slide on a sliding surface (67) of the outer surface (63) of the counter fastening portion (60) along at least one of the longitudinal direction (z) and the circumferential direction (t).

6. The fixing member (100) according to any one of claims 1 to 5, wherein the first fixing element (121) is at least one of elastically movable and elastically deformable relative to the fastening portion (110) in a radial direction (r).

7. 7. The fixing member (100) of claim 6, wherein the first fixing element (121) is biased radially inward and the fixing element (121) is elastically movable or elastically deformable radially outward against a restoring force.

8. The fixing member (100) according to any one of the preceding claims, wherein the first fixing element (121) projects radially inwards from the inner surface (113) of the fastening portion (110).

9. The fixing member (100) according to any one of the preceding claims, wherein the first fixing element (121) comprises a snap element (125) having a tongue (126) extending in the longitudinal direction (z).

10. 10. The fixing member (100) of claim 9, wherein the tongue (126) includes a bottom (134) and a head (135), the bottom (134) and the head (135) being separated along the longitudinal direction (z), the bottom (134) being connected to the fastening portion (110), and the head (135) forming a free end section of the tongue (126).

11. The fixing member (100) according to any one of claims 1 to 10, wherein the first fixing element (121) comprises a distally facing stop surface (130) for engaging a proximally facing counter stop surface (28) of the medicament container (5).

12. The fixing member (100) of any one of claims 1 to 11, wherein the first fixing element (121) includes an inwardly facing surface (124) for engaging an outer surface (163) of a flap portion (162) of a counter fixing structure (170) of the housing side wall (32), the flap portion (162) being at least one of radially movable and deformable, and the first fixing element (121) is configured to bias the flap portion (162) radially inward.

13. The fixing member (100) according to any one of claims 1 to 12, wherein the first fixing element (121) includes side edges (129, 131) extending in a longitudinal direction (z) and protruding at least partially from the inner surface (113) of the fastening portion (110) to engage with a concave counter fixing structure (70; 170) on the outer surface (34) of the housing side wall (32).

14. The fixing member (100) according to any one of claims 1 to 13, wherein the fixing structure (120) further comprises a second fixing element (122) and / or a third fixing element (123) positioned circumferentially offset from the first fixing element (121), extending into the container accommodating space (33), and configured to mechanically engage with the drug container (5) in the container accommodating space (33).

15. 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 radially recessed neck (16); a housing component (30) of said drug delivery device (1), said housing component (30) comprising: a housing side wall (32) extending in a longitudinal direction (z) and enclosing a cartridge receiving space (33) sized to receive said cartridge (10); a counter fastening (60) provided on the outer surface (34) of said housing side wall (32); A housing component (30) comprising: Including, The cartridge assembly (150) comprises: - further comprising a fixing member (100) according to any one of claims 1 to 14, the fastening portion (110) of the fixing member (100) is mechanically engageable with the counter fastening portion (60), and when the fastening portion (110) of the fixing member (100) is mechanically engaged with the counter fastening portion (60), the first fixing element (121) of the fixing structure (120) of the fixing member (100) extends into the container accommodating space (33) and mechanically engages with the neck portion (16) of the cartridge (10); Cartridge assembly (150).

16. 16. The cartridge assembly (150) of claim 15, wherein the housing side wall (32) includes a counter fixing structure (70; 170) having a first through opening (72) extending through the housing side wall (32) and sized to radially receive the first fixing element (121) within or through the first through opening (72).

17. The cartridge assembly (150) of claim 15 or 16, wherein the housing side wall (32) includes a counter fixing structure (170) having a first flap portion (162) movable or deformable in a radial direction (r) relative to the housing side wall (32), the first flap portion (162) including an outer surface (163) for engaging with the first fixing element (121) of the fixing structure (120) of the fixing member (100), and further including an inner surface (164) for engaging with the neck portion (16) of the cartridge (10).

18. A cartridge assembly (150) according to any one of claims 15 to 17, wherein the counter fastening portion (60) includes a tubular side wall portion (62) having an outer sliding surface (67) that enables or supports at least one of longitudinal and circumferential sliding movement of the fastening portion (110) of the fixing member (100) relative to the housing side wall (32).

19. A drug delivery device (1) for expelling a dose of a medicament (26), comprising: a body (6), a drive mechanism (7) including a piston rod (80) for exerting an ejection force on a piston (25) located in a cartridge (10) containing said drug (26); A cartridge assembly (150) according to any one of claims 15 to 18, configured to be removably or non-removably fixed to said body (6); A drug delivery device (1).

20. A method of assembling a cartridge assembly (150) of a drug delivery device (1), comprising the steps of: - inserting a cartridge (10) into the cartridge receiving space (33) of a housing component (30) of a cartridge assembly (150) according to any one of claims 15 to 18; - placing a fixing member (100) according to any one of the preceding claims in a final assembly position on the counter-fastening portion (60) of the housing side wall (32) of the housing component (30); - mechanically engaging said first locking element (121) of said locking structure (120) of said locking member (100) with said neck (16) of said cartridge (10); A method comprising:

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