CARTRIDGE HOLDER AND CARTRIDGE ASSEMBLY FOR AN INJECTION DEVICE - Patent application

Abstract

The present disclosure provides a cartridge assembly and cartridge holder for an injection device, comprising: - an elongate body (29) extending in a longitudinal direction (z), the elongate body (29) including a distal end (24) and a proximal end (23) opposite the distal end (24), the elongate body (29) enclosing a cartridge receiving space (28) for receiving a medicament container (10); a retainer part (30) including a retainer side wall (31) surrounding a distal portion of the cartridge receiving space (28), the retainer part (30) including a proximal end (33); - a connector part (40) including a connector side wall (41) and a distal connector (43) configured to connect to a proximal end (33) of the retainer part (30), the connector part (40) including a proximal connector (59) configured to connect to a distal end (79) of a device body (6) of an injection device (1), the device body (6) being configured to accommodate a drive mechanism (7) that operatively engages with a medicament container (10); The present invention relates to a cartridge holder comprising:

Description

[Technical field]

[0001] The present disclosure relates to a cartridge holder, a cartridge assembly, and a container assembly for an injection device. The present disclosure further relates to an injection device and a method of assembling an injection device. [Background technology]

[0002] Drug delivery devices that allow for multiple administration of a required dose of a liquid drug and further provide for administration of such a liquid drug to a patient are well known as such in the prior art. Generally, such devices have substantially the same purpose as that of a conventional syringe. Typically, the drug to be administered is provided in a cartridge having a movable piston or bung that mechanically interacts with a piston rod of a drive mechanism of the drug delivery device. By applying a thrust to the piston, a specific, predetermined amount of the drug fluid is expelled from the drug container.

[0003] 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.

[0004] Another concern may arise that cartridges are manufactured in essentially standard sizes 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 medicament into the 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.

[0005] 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.

[0006] Therefore, in order to prevent undesired cross-use of cartridges, it is generally necessary to physically dedicate or mechanically code the cartridge and / or cartridge holder to the drug type and to design an injection device that accepts or functions only with the dedicated or coded features provided on or in the cartridge and / or cartridge holder. For this purpose, it is generally conceivable to provide a dedicated cartridge assembly, i.e. a cartridge holder with a cartridge or drug container readily assembled therein. In this case, the cartridge may be non-removably fixed in the cartridge holder. The cartridge holder may be individually dedicated or physically coded according to a particular type of cartridge and / or the particular drug contained in such cartridge or drug container.

[0007] In the case of a reusable injection device, the cartridge or drug container must be replaced when the drug is exhausted. In a cartridge assembly including a cartridge holder in which a cartridge is fixed, it may be intended to discard the entire cartridge assembly and replace it with a new one. In this case, on the one hand, the discarding of the entire cartridge holder may have a negative impact on the ecological footprint of the injection device. On the other hand, it is desirable to irreversibly mechanically dedicate or irreversibly connect the cartridge and the correspondingly coded cartridge holder to prevent unintended cross-use of the cartridge with the wrong injection device or drive mechanism.

[0008] Thus, there is a general need for specialized cartridges that allow medical delivery devices to be used only with authorized cartridges containing specific medications, while also preventing unwanted cross-use of cartridges.

[0009] In drug delivery devices that include a multi-part housing, for example having a first housing component and a second housing component, it is also desirable to provide a fail-safe, well-defined mechanical connection between the housing components, which may be detachably or non-detachably connectable. Summary of the Invention [Means for solving the problem]

[0010] In one aspect, the present disclosure relates to a cartridge holder for an injection device, such as an injection pen. The cartridge holder includes an elongated body extending in a longitudinal direction. The elongated body includes a distal end and a proximal end. The proximal end is located opposite the distal end. The elongated body encloses a cartridge receiving space for receiving a medicament container, typically embodied as a cartridge. The cartridge holder further includes a retainer part including a retainer sidewall that encloses a distal portion of the cartridge receiving space. The retainer part includes a proximal end. The cartridge holder further includes a connector part including a connector sidewall and a distal connector. The distal connector is configured to mechanically connect to the proximal end of the retainer part. The connector part further includes a proximal connector configured to connect to a distal end of a device body of an injection device. The device body is configured to house or receive a drive mechanism. The drive mechanism is configured to operatively engage the medicament container.

[0011] In some examples, the cartridge holder constitutes or forms a distal housing component of the injection device, while the body constitutes or forms a proximal housing component of the injection device. In some examples, the device body and the cartridge holder are detachably or removably connectable. In some examples, the injection device is embodied as a reusable injection device, where the cartridge holder can be removed from the device body to replace the drug container.

[0012] In some examples of cartridge holders, the retainer part is a reusable component and the connector part is a disposable component, where it may be intended or necessary to detach the retainer part from the connector part to provide access to the drug container for replacement.

[0013] In some examples, the proximal connector of the connector part is mechanically coded according to the drug container and / or according to the drug provided in the drug container. The mechanical coding of the proximal connector allows mechanical connection of the cartridge holder to a suitable or dedicated device body provided with a suitable drive mechanism. In this way, unintended cross-use of the cartridge holder with an incompatible device body or an incompatible drive mechanism can be effectively prevented. Thus, patient safety can be increased and misuse of the injection device, i.e. improper or unintended connection of the cartridge holder to an incompatible device body, can be effectively avoided.

[0014] Additionally, the connector parts may include or provide mechanical adapters for mounting the retainer parts to different types of device bodies. Thus, different configurations of connector parts may be provided, each of which includes the same distal connector for connecting to a single type or shape of retainer part.

[0015] In a set or kit of connector parts of different configurations, the proximal connectors of each connector part may be distinguished from one another. Thus, a first connector part of a kit or set of connector parts comprises a distal connector of a first type and a proximal connector of a first type. A second connector part comprises the same distal connector of the first type, but a proximal connector of a second type. The first proximal connector and the second proximal connector are distinguished from one another. The first proximal connector is connectable to a device body of a first type, but not connectable to a device body of a second type. Conversely, the second type proximal connector is connectable to a device body of a second type, but is not compatible with a device body of a first type. Incompatible pairs of proximal connectors and device bodies cannot be connected to one another.

[0016] In this way, the cartridge holder can be mechanically coded by selecting the appropriate connector part that fits each drug container. In view of this, container assemblies, i.e. matching pairs of connector parts and drug containers, can be provided. Such container assemblies may be commercially available from drug container manufacturers. The container assemblies may be connectable to the same type of retainer part, which is a reusable part. Such a reusable retainer part can be used sequentially with a series of container assemblies.

[0017] The retainer parts may also be universally usable and connectable to different types of container assemblies, each container assembly being specialized and configured for mechanical connection to only one particular device body with a corresponding drive mechanism.

[0018] The presently proposed cartridge holder offers the advantage of reusing the retainer parts for a wide variety of different configurations of connector parts and therefore different configurations of device bodies of the same or different types of injection devices. In this way, the production costs of the retainer parts can be reduced. Furthermore, the ecological footprint of the cartridge holder and thus the entire injection device can be reduced.

[0019] By embodying the connector parts as sole or exclusively disposable components, the total number of reusable components or parts of the injection device can be increased compared to dedicated or coded cartridge holder solutions that are configured or intended to be discarded in their entirety after use with the cartridge immovably secured therein.

[0020] According to a further example, the retainer part, and thus the retainer sidewall, encloses a majority of the cartridge-receiving space. A minority of the cartridge-receiving space may be enclosed by the connector part. Thus, both the retainer part and the connector part may contribute to a housing that encloses the cartridge-receiving space. The cartridge-receiving space is defined by the volume inside the cartridge holder that is completely occupied by the drug container, e.g. embodied as a cartridge.

[0021] Thus, the connector sidewall and the retainer sidewall are longitudinally adjacent and may be arranged in a partially nested or overlapping configuration such that at least a portion of the connector sidewall and at least a portion of the retainer sidewall exclusively define or contribute to the enclosure of the cartridge-receiving space.

[0022] According to a further example, when the connector part is connected to the retainer part, the connector sidewall forms a longitudinal extension of the retainer sidewall, where the connector sidewall and the retainer sidewall may be longitudinally flush. In particular, an inner surface of the connector sidewall may be flush with an inner surface of the retainer sidewall. Also, an outer surface of the connector sidewall may be flush with a corresponding outer surface of the retainer sidewall.

[0023] In some examples, the connector part is located longitudinally between the retainer part and the device body. Thus, the retainer part and the device body are not mechanically engaged. The retainer part and the device body are longitudinally offset from one another. The longitudinal gap between the retainer part and the device body is filled or occupied by the connector part. In other words, the retainer part is exclusively connectable to the connector part. The retainer part is indirectly connectable to the device body only by the connector part. In this manner, the connector part provides a mechanical adapter for securing and connecting the retainer part to the device body.

[0024] According to a further example, the connector side wall of the connector part surrounds the proximal part of the cartridge receiving space. In this case, the connector side wall may surround the outer periphery of the cartridge receiving space, which may be, for example, tubular. In a further example, the connector side wall or the connector part may also surround the cartridge receiving space in the longitudinal direction.

[0025] According to a further example, the connector part includes a flange portion extending radially inward from the connector sidewall. The flange portion includes a distally facing stop surface configured to abut the proximal end of the drug container. Typically, the drug container, for example embodied as a cartridge, includes a tubular barrel. The tubular barrel may be made of a vitreous material, such as glass. The proximal end of the drug container barrel may abut longitudinally with a distally facing stop surface of the flange portion projecting or extending radially inward from the connector sidewall. In this way, the connector provides a double or two functions. On the one hand, the connector provides a mechanical connection between the device body and the retainer portion of the cartridge holder. On the other hand, the connector part provides a longitudinal fixation of the drug container in the cartridge receiving space.

[0026] Typically, and in further examples, the retainer part includes a proximally facing stop surface for engaging a complementary shaped distally facing end surface or shoulder of the barrel of the medicament container, for example on a distally located end wall of the retainer part or in the region of a narrowing shoulder of a retainer side wall. In this manner, the medicament container located within the cartridge receiving space can be longitudinally secured by mechanically attaching the connector part to the retainer part, for example by establishing a mechanical connection between a distal connector of the connector part and a proximal end of the retainer part.

[0027] Typically, in some instances, the medicament container may be clamped or at least enclosed longitudinally between a proximally facing stop surface of the retainer part and a distally facing stop surface of the flange portion of the connector part when the distal connector of the connector part engages the proximal end of the retainer part, thus providing longitudinal fixation of the medicament container within the cartridge-receiving space in both the distal and proximal directions.

[0028] According to a further example, the distal connector of the connector part and the proximal end of the retainer part are configured to form at least one of a tension-stable mechanical connection and a pressure-stable mechanical connection. When providing a tension-stable mechanical connection, a distal tensile force applied to the cartridge holder can be transferred to the device body via the connector part. Thus, a distal tensile force applied to the cartridge holder can be transferred and induced unchanged to or on the connector part and can be transferred to the device body as well by its tension-stable and / or pressure-stable connection with the device body.

[0029] Due to the pressure-stable mechanical connection, the proximal forces applied to the cartridge holder are transferred unchanged to or to the connector part. The effect of each proximal thrust or force can then be transferred unchanged to or to the device body of the injection device. Due to the longitudinally-viewed tension- and pressure-stable mechanical connection, the retainer part and the connector part can be connected to each other in a fairly rigid manner, thereby providing a fairly stable long-term interconnection between the retainer part and the connector part as well as between the retainer part and the device body. The interconnection between the connector part and the retainer part may be free of mechanical play. In this way, the user of the injection device can get the impression that the cartridge holder made of the retainer part and the connector part is a single or integral component.

[0030] According to further examples, the elongate body of the cartridge holder is formed by the interconnection of a retainer part and a connector part. In some examples, the retainer part and the connector part constitute the elongate body of the cartridge holder. The cartridge holder may comprise a retainer part and a connector part that are attached to each other and secured to each other.

[0031] According to a further example, the connector part includes a receptacle for receiving a proximal end of the medicament container. In this case, the connector sidewall may constitute or provide at least a part of the enclosure of the cartridge-receiving space. In this way, upon disconnection of the retainer part and the connector part, at least a proximal part of the medicament container may protrude in a longitudinal direction, e.g., proximally from the proximal end of the retainer part. This allows and facilitates removal of the medicament container from, e.g., a reusable retainer part.

[0032] In some examples, the longitudinal extent of the retainer part is greater than the longitudinal extent of the connector part. The longitudinal extent of the retainer part may be twice the longitudinal extent of the connector part. The longitudinal extent of the retainer part may be three times the longitudinal extent of the connector part. In further examples, the longitudinal extent of the retainer part is four times, five times, or even six times greater than the longitudinal extent of the connector part.

[0033] In this way, the proportion of reusable parts or portions of the cartridge holder can be increased compared to the proportion of disposable parts or portions of the cartridge holder, thus improving the ecological footprint of the cartridge holder and thus the injection device.

[0034] According to a further example, the connector part includes a container fastener configured to mechanically engage with a proximal end of the medicament container. Via the container fastener, the connector part may be releasably or non-releasably connected with the medicament container. The connector part, which is fixed or attached to the medicament container, may comprise or constitute the container assembly. The medicament container may be characterized using the connector part, which may be mechanically coded according to the medicament container and / or according to the medicament contained therein. The connector part may be connectable with any of the available retainer parts to form a cartridge holder.

[0035] The proximal connector of the connector part and / or the proximal end of the connector part may be mechanically coded to prevent unauthorized or unintended connection with a device body of an infusion device with an incompatible drive mechanism. The container fastener may be embodied in many different ways. In some examples, the container fastener provides a friction fit with the drug container, for example with an outer surface of the barrel of the drug container. In other examples, the container fastener may include or provide an adhesive or welded connection with the barrel of the drug container. In further examples, a form closure or a secure fit may be provided between the container fastener and the drug container.

[0036] According to a further example, the container fastener is configured to non-detachably connect to the medicament container. The container fastener may be clamped, glued or welded to the medicament container. Any attempt by a user to remove the container fastener and thus the connector part from the medicament container may result in destruction of at least one of the medicament container and the connector part. In this way, unauthorized use of the cartridge holder and / or the medicament container can be effectively avoided. Counterfeiting of the cartridge holder and / or unintentional or unauthorized refilling or replacement of the cartridge holder with an unauthorized medicament container can be effectively prevented.

[0037] According to a further example, the container fastener includes a first fastening rib and a second fastening rib on opposite sides of the cartridge receiving space. The first fastening rib and the second fastening rib are configured to frictionally engage with the barrel of the drug container. Here, the fastening rib may be made of a friction-enhancing material. The fastening rib may include a friction surface facing or extending toward the cartridge receiving space. The fastening rib may be made of a resilient material, such as an injection moldable plastic material, and / or an elastomeric material that provides a friction lock between the fastening rib and the barrel of the drug container when the drug container is inserted into a receptacle, for example formed by a connector side wall of the connector part.

[0038] In some examples, the first fastening rib and / or the second fastening rib may project radially inward into the cartridge receiving space such that the medicament container can be inserted into the cartridge receiving surface only by radially outward elastic deformation of the first fastening rib and / or the second fastening rib. In this way, a fairly stable and efficient friction lock can be provided between the fastening rib and the barrel of the medicament container.

[0039] According to a further example, at least one of a first fastening rib and a second fastening rib projecting distally from a distal end face of the connector part engages with a complementary shaped recess in the retainer part when the connector part is connected to the retainer part, and the distally projecting fastening rib may provide a guiding function for establishing a mechanical connection between the distal connector of the connector part and the proximal end of the retainer part.

[0040] In some examples, the distal connector may also project distally from the distal end of the connector part and / or from the connector sidewall, in which case the fastening ribs may also project distally from the distal connector and thus provide proper circumferential alignment to allow for smooth and easy connection of the retainer part and the connector part.

[0041] In this respect, the first fastening rib and the second fastening rib may also provide the function of guide ribs for establishing accurate alignment of the retainer part and the connector part during the mutual assembly of the retainer part and the connector part.

[0042] According to a further example, one of the proximal end and the distal connector includes a fastening element that is complementary in shape to a counter fastening element of the other of the proximal end and the distal connector. In this regard, for example to provide a releasable connection between the retainer part and the connector part, the proximal end may include a fastening element and the distal connector may include a complementary in shape counter fastening element.

[0043] According to further examples, one of the fastening element and the counter-fastening element includes a recess. The other of the fastening element and the counter-fastening element includes a catch element configured to engage with the recess. In some examples, the recess is provided in a side wall of one of the retainer part and the connector part. Thus, the catch element may be provided on or protrude from the side wall of the other of the retainer part and the connector part.

[0044] The recess may be provided at a proximal end of the retainer sidewall. The recess may be accessible or may be provided at an inner portion of the retainer sidewall. The catch element may be provided at an outwardly facing portion of the connector sidewall. In this case, the proximal end of the retainer part may include a receptacle for receiving at least a complementarily shaped insert section of the distal end of the connector sidewall. In this manner, an at least partially overlapping or nested configuration of the retainer part and the connector part may be provided, thereby providing a fairly stable and robust interconnection between the retainer part and the connector part.

[0045] According to a further example, the catch element of one of the retainer part and the connector part extends in the longitudinal direction and is configured to engage with a recess provided in a connector side wall or a retainer side wall of the other of the retainer part and the connector part.

[0046] According to a further example, the catch element is radially deformable or movable to engage and / or disengage from the recess, where the radial direction extends substantially perpendicular to a longitudinal direction (z) defined by the elongate shape of the elongate body or cartridge holder.

[0047] In a further example, the catch element may protrude distally from the connector sidewall, where the connector sidewall may include a distally facing stop surface that is complementary in shape to the proximally facing end surface of the retainer sidewall. The catch element, or several catch elements, may protrude distally from the inside of the connector sidewall of the connector part and may engage a recess provided on the inside of the retainer sidewall when the proximal end surface of the retainer sidewall engages or abuts the distal end surface of the connector sidewall.

[0048] The longitudinal extension of at least one or several of the catch elements from the inner surface of the connector side wall provides the advantage that the respective counter-fastening element is practically invisible from outside the cartridge holder when the retainer part and the connector part are assembled with one another. In a further example, it is conceivable that the connector part comprises a recess in the connector side wall and the retainer part comprises a longitudinally extending, e.g. longitudinally projecting, catch element for engaging with a corresponding recess.

[0049] In some examples, the recesses in the side walls of the retainer part or connector part are embodied as through-recesses. In this way, it may primarily be possible to insert a specially designed tool into the recess from the outside, so as to push the catch element out of the recess when it engages with the recess. The interconnection between the retainer part and the connector may then be released or released.

[0050] The catch element may include a protrusion and / or bevel shape to deform or move radially during the course of mutual assembly of the retainer part and the connector part. Upon reaching the final assembled configuration, e.g., when a distal end face of the connector sidewall engages a proximal end face of the retainer sidewall, the catch element may reach and / or overlap the recess and relax to its initial state, thereby engaging the recess.

[0051] In some examples, the catch element includes a barb or hook shape that engages with the recess to provide a tension stable connection between the retainer part and the connector part.

[0052] In a further example, a radial gap is provided between the inside of the catch element and the outside of the drug container or cartridge receiving space, including a radial gap size greater than or equal to the travel distance required to disengage the catch element from the recess. In this respect, in a substantially tubular cartridge receiving space, the inside of the retainer or connector part may be somewhat elliptical or oval in shape such that a radial gap of a predetermined size is provided that allows for radially inward deformation or movement of the catch element to provide a clearly defined disengagement of the catch element with the recess and thus a respective disengagement of the counter fastening element of a complementary shape to the fastening element of the proximal end and the distal connector.

[0053] According to a further example, the distal connector includes a predetermined break structure, which may include a predetermined break point, configured to break the distal connector apart when a user attempts to disengage the distal connector from the proximal end of the retainer component.

[0054] In this way, it can be ensured that the cartridge holder, including the retainer part and the connector part attached thereto, can be disassembled into the retainer part and the connector part. However, when the connector part is separated from the retainer part, the distal connector falls apart and can no longer be used to reattach the retainer part. In this case, the user of the injection device must discard the connector part, e.g. fixedly attached or fixedly connected to the drug container. The user may then have to use a pre-assembled configuration of another container assembly, e.g. a new drug container with a new connector part. A new drug container with a new connector part may then be inserted into the retainer part, and the new connector part configured as a disposable component can be connected with the retainer part embodied as a reusable component, thereby forming a new cartridge holder.

[0055] The predetermined breaking structure may comprise, for example, a structural weakening in the catch element or in or on the recess, depending on the particular implementation of the fastening element or counterfastening element of the distal connector of the connector part.

[0056] According to a further example, the connector part comprises a mechanical coding element for mechanically engaging with a complementary shaped mechanical counter-coding element on the device body. In this way, a connector part that is, for example, non-detachably fixed or connected with a dedicated drug container can be used only with the intended or dedicated device body or drive mechanism of the infusion device. The mechanical coding element of the connector part prevents unintended cross-use of the connector part with a drug container that is not intended for use with the device body and / or corresponding drive mechanism.

[0057] According to another aspect, the present disclosure further relates to a cartridge assembly, which includes the cartridge holder as described above and further includes a drug container, e.g. in the form of a cartridge, disposed within a cartridge receiving space of the cartridge holder. In this respect, all features, effects, and advantages described above in relation to the cartridge holder apply equally to the cartridge assembly. In some examples, the cartridge assembly includes a drug container fixedly disposed therein. The drug container may be immovably fixed within a cartridge receiving space defined by the cartridge holder, e.g. formed by a retainer part connected with a connector part.

[0058] According to another aspect, the present disclosure further relates to an injection device for setting and injecting a dose of a medicament. The injection device includes a device body, for example forming or constituting a proximal housing of the injection device. The injection device further includes a drive mechanism arranged within the device body. The drive mechanism is configured to operatively engage a medicament container containing the medicament. The drive mechanism typically includes a piston rod for exerting a distal driving or ejecting force on a stopper of the medicament container to eject a dose of the medicament from the medicament container. The injection device further includes one of the above-mentioned cartridge holder and the above-mentioned cartridge assembly connectable or actually connected to a distal end of the device body. It is noted that the injection device includes the above-mentioned cartridge holder and / or cartridge assembly. In this respect, all features, effects and advantages described above in connection with the cartridge holder and cartridge assembly apply equally to the injection device.

[0059] According to a further aspect, the present disclosure further relates to a kit or set of injection devices. The kit includes a first injection device comprising a first device body, a first drive mechanism, and one of a first cartridge holder and a first cartridge assembly. The kit further includes a second injection device comprising a second device body, a second drive mechanism, and one of a second cartridge holder and a second cartridge assembly. The first drive mechanism and the second drive mechanism may be of different configurations. The first drive mechanism and the second drive mechanism may be suitable for and intended for different types of drug containers or drugs.

[0060] The first and second device bodies may be distinguished from one another by at least one of a counter fastening element and a counter coding element provided at or near a distal end of the device body. The counter fastening element is configured to mechanically engage with a complementary shaped fastening element of a matching cartridge holder. The counter coding element may be configured to mechanically engage only with an appropriate coding element provided at or near a proximal connector of the cartridge holder.

[0061] The first cartridge holder or cartridge assembly is differentiated from the second cartridge holder or cartridge assembly by their first and second connector parts. The first and second cartridge holders, and thus the first and second cartridge assemblies, may include a common and therefore identical retainer part. Thus, the first cartridge holder and / or the first cartridge assembly and the second cartridge holder and cartridge assembly may be provided with an identical retainer part including a proximal end configured to connect to either the distal connector of the second connector part or the distal connector of the second connector part. The first and second connector parts of the first and second cartridge holders include distal connectors of equal shape or equal configuration.

[0062] The first and second cartridge holders and / or the first and second connector parts of the first and second cartridge assemblies are distinguished by their proximal connectors and / or by coding elements configured to mechanically engage with complementarily shaped counter coding elements on the first and second device bodies.

[0063] In this way, the first cartridge holder of the first injection device can be used exclusively with the first device body and thus with the first drive mechanism of the first injection device. The first cartridge holder of the first injection device cannot be connected or used with the second device body or the second drive mechanism. Conversely, the cartridge holder or the second cartridge assembly can be used only with the second device body and / or the second drive mechanism. Unintended cross-use of the first cartridge holder with the second device body or the second drive mechanism as well as use of the second cartridge holder with the first device body or the first drive mechanism are effectively prevented.

[0064] According to another aspect, the present disclosure also relates to a container assembly for an injection device. The container assembly includes a medicament container including a barrel filled with a medicament. The container assembly further includes a cartridge holder connector part as described above, where the connector part is connected or fixed to the medicament container. The connector part may be permanently or removably fixed to the medicament container in a manner as described above in relation to the container fastener of the cartridge holder connector part.

[0065] In this regard, the container assembly uses the connector part of the cartridge holder described above, and therefore all of the features, effects, and advantages described above in relation to the connector part of the cartridge holder apply equally to the container assembly. The container assembly may be pre-configured in the sense that the drug container is pre-assembled with the connector part when commercially distributed to a healthcare provider and / or patient. The container assembly may be embodied as a disposable assembly configured for use with a reusable retainer part of the cartridge holder and for use with a reusable device body and / or a reusable drive mechanism of the injection device.

[0066] According to another aspect, the present disclosure further relates to a container assembly kit or a container assembly set. The container assembly kit includes a first container assembly as described above. The first container assembly includes a first drug container and a first connector part connected or secured to the first drug container, the first connector part including a first proximal connector and a first distal connector. The container assembly kit further includes a second container assembly as described above. The second container assembly includes a second drug container and a second connector part connected or secured to the second drug container, the second connector part including a second proximal connector and a second distal connector.

[0067] In the container assembly kit, the first drug container is distinguished from the second drug container, for example by its geometric shape or size and / or by the drug contained therein. The first proximal connector is also distinguished from the second proximal connector. In this way, the first container assembly can only be used with a first device body or a first drive mechanism of an infusion device, but not with a differently configured second device body or a second drive mechanism of another infusion device.

[0068] According to a further example, the first distal connector is substantially identical to the second distal connector. In this way, the same retainer part can be used for the first and second container assemblies to establish or provide a cartridge holder. The retainer part can be connected to both the first and second distal connectors, thereby forming or constituting a cartridge assembly including the above-mentioned cartridge holder and including a drug container disposed in its cartridge receiving space. Such a cartridge holder can then be releasably connected to the distal end of the device body of the injection device.

[0069] In a further aspect, the present disclosure relates to a method for assembling the cartridge assembly and / or injection device as described above, wherein, as a first step, a medicament container, e.g. a cartridge and a cartridge holder, e.g. a connector part of the cartridge holder as described above, are provided. The medicament container is then connected with the connector part. In this way, the container assembly as described above can be provided. In a next step, the container assembly, and thus the medicament container with the connector part, is inserted into the retainer part of the cartridge holder. Here, the distal end of the medicament container is inserted distally into the retainer part. Then, when the final assembly position is reached, the connector part and the retainer part are connected to each other. Typically, the connector part and the retainer part are assembled to each other and attached to each other. Here, the distal connector of the connector part engages with the proximal end of the retainer part. A fastening element of the retainer part, e.g. provided on the retainer side wall, engages with a complementary shaped counter fastening element of the distal connector of the connector part.

[0070] Then, in a further step, the cartridge assembly, i.e. the cartridge holder with the medicament container assembled therein, is attached and connected to the device body, thus forming or constituting the injection device, where in particular the connector part of the cartridge holder is connected with the device body, thereby forming or constituting the injection device.

[0071] In general, the method of assembling the cartridge holder and / or injection device is carried out by the cartridge holder and injection device described above. In this regard, all features, effects and advantages described above in relation to any one of the cartridge holder, cartridge assembly, container assembly, injection device and associated kits apply equally to the method of assembling the cartridge assembly and / or injection device, and vice versa.

[0072] 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.

[0073] 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.

[0074] 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.

[0075] As described below, the 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. The nucleic acids may be incorporated into a molecular delivery system such as a vector, a plasmid, or a liposome. Mixtures of one or more drugs are also contemplated.

[0076] 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.

[0077] 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.

[0078] 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.

[0079] 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.

[0080] 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.

[0081] 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.

[0082] 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.

[0083] Examples of DPP4 inhibitors are linagliptin, vildagliptin, sitagliptin, denagliptin, saxagliptin, berberine.

[0084] 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.

[0085] 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.

[0086] 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).

[0087] 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.

[0088] The term "complementarity determining region" or "CDR" refers to short polypeptide sequences within the variable regions of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term "framework region" refers to amino acid sequences within the variable regions of both heavy and light chain polypeptides that are not CDR sequences 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 within the CDR to interact with the antigen.

[0089] 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).

[0090] 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.

[0091] 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.

[0092] Exemplary drug delivery devices may include needle-based injection systems as described in Table 1 of Section 5.2 of ISO 11608-1:2014(E). As described in ISO 11608-1:2014(E), needle-based injection systems may be broadly divided into multi-dose container systems and single-dose (partial or full discharge) container systems. The container may be a replaceable container or may be an integrated non-replaceable container.

[0093] As further described in ISO 11608-1:2014(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 with integrated non-replaceable containers. In such systems, each container holds multiple doses and the size may be fixed or variable (pre-set by the user).

[0094] As further described in ISO 11608-1:2014(E), the single-dose container system may include a needle-based injection device with a replaceable container. In one example of such a system, each container holds a single dose, which 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 ISO 11608-1:2014(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).

[0095] 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.

[0096] In the following, examples of a cartridge holder, a cartridge assembly, a container assembly and an injection device are described in more detail with reference to the drawings. [Brief description of the drawings]

[0097] [Figure 1] 1 shows an example of an injection device. [Diagram 2] FIG. 2 illustrates a side view of an example cartridge holder. [Diagram 3] FIG. 3 shows a perspective view of the cartridge holder of FIG. 2; [Figure 4] FIG. 13 is an exploded view of the connector parts of the cartridge holder. [Diagram 5] FIG. 2 is a perspective view of a cartridge assembly. [Figure 6] 1 shows two examples of cartridge holders with different configurations. [Figure 7]FIG. 2 is a longitudinal cross-sectional view of the cartridge assembly. [Figure 8] FIG. 2 is a cross-sectional view of the cartridge assembly. [Figure 9] FIG. 2 is a cross-sectional view of the cartridge assembly. [Figure 10] FIG. 13 is an enlarged longitudinal cross-sectional view of the junction of the cartridge holder and the distal end of the device body. [Figure 11] FIG. 2 is a longitudinal cross-sectional view of the cartridge assembly. [Figure 12] FIG. 12 is an enlarged view of the proximal end of the view of FIG. [Figure 13] FIG. 13 is a close-up view of the interconnection between the retainer part and the connector part. [Figure 14] FIG. 13 is a further longitudinal cross-sectional view of the cartridge assembly. [Figure 15] FIG. 15 is an enlarged cross-sectional view of the proximal end of the cartridge assembly of FIG. [Figure 16] FIG. 13 is an enlarged view of the joint between the retainer part and the connector part. [Figure 17] FIG. 13 is a partial view of the interface between the cartridge holder and the device body. [Figure 18] 1 is a flow chart of a method of assembling a cartridge assembly. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0098] FIG. 1 shows an example of a drug delivery device embodied as an injection device 1, such 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 embodied as a cartridge holder 20 sized to accommodate a medicament container 10. The injection device 1 further comprises a device body 6 forming or constituting a proximal housing component. The device 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 16 contained in a medicament container 10, which in the present case may be embodied as a cartridge 11. Typically, the drive mechanism 7 comprises a piston rod 4, for example with a pressure piece 5 at its distal end. The pressure piece 5 is configured to abut in the longitudinal direction (z) against a proximal end face of a piston 15 slidably arranged in a barrel 12 of the cartridge 11. The piston 15 is shown for example in FIG. 7.

[0099] Barrel 12, which may be of a vitreous material such as glass, includes a sidewall 13 having a substantially tubular main portion 14. A piston 15 is slidably movable along main portion 14. Main portion 14 merges toward a discharge end 17 into a narrowing shoulder which further merges into a radially stepped narrowing neck.

[0100] The injection device 1 further comprises a protective cap 68 configured to cover the discharge end 24 of the injection device 1. The cartridge holder 20 comprises a distal end 24 and a proximal end 23. The distal end 24 is configured to engage with a needle assembly, e.g. a double-ended injection needle, by which a dose of liquid medicament 16 can be injected into biological tissue. To this end, the distal end 24 of the cartridge holder 20 comprises a mechanical connector 25, e.g. embodied as a threaded section 27, which supports and enables a mechanical, i.e. threaded, connection with a complementary shaped needle hub provided with the injection needle.

[0101] The distal end 24 of the cartridge holder 20 further includes an aperture 26 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 18 at the distal end of the cartridge 11. The seal 18 may include a pierceable septum, which is secured to the distal head of the cartridge 11 by a septum retainer 19. The septum retainer 19 may include a beaded cap made of a flexible material such as aluminum or plastic.

[0102] The septum retainer 19 includes an aperture that aligns with the aperture 26 when the cartridge 11 is received within the cartridge holder 20. The cartridge holder 20 includes a cartridge-receiving space 28 that is substantially occupied by the cartridge 11 when assembled therein. The cartridge holder 20 includes a proximal end 23 that may include an insert 42 sized and configured for insertion into a receptacle 72 provided at a distal end of the device body 6. The insert 42 is bounded in the distal direction 2 by a flange portion 64. When the cartridge holder 20 is attached to a device body 6 forming or constituting the injection device 1, the flange portion 64 may abut longitudinally against a side wall 71 of the receptacle 72 or a distal end face of the device body 6.

[0103] The interior of the receptacle 72 may be provided with a counter fastening element 73, 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 42. In this way, the proximal end of the cartridge holder 20 can be fixedly attached to the body 6.

[0104] Optionally, the proximal end 23 of the cartridge holder 20 includes a coding element 54 by which the cartridge holder 20 and / or cartridge assembly 100 can be mechanically coded and distinguished from another cartridge holder 20' or cartridge assembly 100', for example with a different type of cartridge 11 or with a cartridge containing a different medicament 16. The coding element 54 or coding feature may be complementary in shape or arrangement to a counter coding element 74 provided on or in the device body 6. A mismatched pairing of the coding element 54 and the counter coding element 74 may prevent interlocking of the cartridge holder 20 to the body 6.

[0105] Mutual fastening and fixation of the cartridge holder 20 to the device body 6 can only be provided and made possible when the coding element 54 of the cartridge holder 20 matches in size, shape and position with a corresponding counter coding element 74 provided on or within the device body 6.

[0106] In Figures 2 and 3 the cartridge holder 20 of the injection device 1 is shown in more detail. The cartridge holder 20 comprises a substantially tubular side wall 21. The cartridge holder 20 comprises a proximal connecting end 22 for interconnecting with the distal end 79 of the device body 6. The cartridge holder 20 comprises an elongate body 29 extending in a longitudinal direction (z). Towards the distal end 24 the elongate body 29 comprises a connector 25. Towards the proximal end the body 29 comprises a connecting end 22 for detachably interconnecting with the device body 6.

[0107] As will be particularly apparent from FIGS. 2-5, the cartridge holder 20 includes a retainer part 30 and a connector part 40. The connector part 40 forms the proximal end 23 of the cartridge holder 20. The retainer part 30 forms or constitutes the distal end 24. The retainer part 30 includes a retainer sidewall 31 surrounding a distal portion of the cartridge receiving space 28. The connector part 40 includes a connector sidewall 41. As shown in FIG. 2, the connector sidewall 41 and the retainer sidewall 31 are substantially flush in the longitudinal direction. In this respect, when the connector part 40 is connected to the retainer part 30, the connector sidewall 41 is or forms a longitudinal extension of the retainer sidewall 31. At the joint between the retainer part 30 and the connector part 40, a radially outwardly protruding annular flange portion 64 may be provided.

[0108] Flange portion 64 may be provided at or near the distal end of connector part 40. Flange portion 64 may include a proximally facing abutment surface that engages an end surface of sidewall 71 of device body 6, for example.

[0109] The retainer part 30 includes a proximal end 33 configured to engage with the connector part 40. The connector part 40 includes a distal connector 43 for establishing a mechanical connection with the proximal end 33 of the retainer part 30. The distal connector 43 includes two counter fastening elements 45, each of which is embodied as a catch element 46 featuring a radially outwardly extending projection 47 that projects distally from a distally facing end surface 44 of the connector side wall 41 at a distal end of a longitudinal extension. The counter fastening elements 45 are configured to engage with a fastening element 35 provided on or in the proximal end 33.

[0110] The catch element 46 includes a beveled edge 48 facing radially outward and in the distal direction 2. The counter fastener element 45 engages the proximally facing end surface 34 of the retainer sidewall 31 during insertion of the counter fastener element 45 into the proximal end of the open end of the retainer sidewall 31 to interconnect the retainer part 30 and the connector part 40 to one another.

[0111] In this manner, the counter fastening element 45, and thus the catch element 46, resiliently deform radially inward to permit and support its distal insertion into the receptacle 32 provided at the proximal end 33. Upon reaching the final assembled configuration, for example in which the end face 34 of the retainer side wall 31 longitudinally abuts the complementarily shaped end face 44 of the connector side wall 41, the protrusion 47 of the catch element 46 engages and snaps into the recess 36 of the fastening element 35, thereby locking the connector part 40 in place in the retainer part 30.

[0112] This type of connection is both tension and pressure stable.

[0113] The recess 36 is embodied as a through recess. By utilizing a tool of a particular shape, shaped and designed to be inserted into the recess 36 from the outside, it is possible to bias the projection 46 and thus the catch element 46 radially inwards, thereby disengaging it from the recess 36 and thereby disengaging the counter fastening element 45 of the connector part 40 from the fastening element 35 of the retainer part 30.

[0114] In this respect, the connector part 40 and the retainer part 30 can be removably connected. When the connector part 40 is mounted and fixed to the retainer part 30, the connector part 40, in particular the connector side wall 41, protrudes in the proximal direction 3 from the retainer side wall 31. The connector side wall 41 forms an insert 42 for insertion into a receptacle 72 of the body 6. On the inner side of the side wall 71 of the receptacle 72, at least one counter fastening element 73 is provided, which is configured to engage with a fastening element 53 provided on the outer surface of the connector side wall 41. Here, the fastening element 53 may include one of a protrusion and a recess.

[0115] 2 and 3, the fastening element 53 includes a fastening protrusion 55. The fastening element 53 and the counter-fastening element 73 may be configured to provide a detachable or releasable mechanical interconnection. The fastening element 53 and the counter-fastening element 73 may be configured to provide one of a bayonet joint, a screw joint, or a clip joint.

[0116] The connector part 40 further comprises a coding element 54, which is provided on the outer surface of the connector side wall 41. The coding element 54 is configured to mechanically engage with a complementary shaped counter-coding element 74 provided on the inner surface of the side wall 71 of the receptacle 72 of the device body 6. The coding element 54 comprises a coding protrusion 56 which matches and / or engages with a complementary shaped coding recess of the counter-coding element 74 of the device body 6. The coding element 54 may be coded by its geometry and / or by its placement and position or orientation relative to the fastening element 53.

[0117] Additionally, the proximal end face 60 of the connector sidewall 41 may also have a non-flat profile when viewed circumferentially and longitudinally, where the profiled sawtooth, undulating or wavy structure of the proximal end face 60 of the connector sidewall 41 likewise serves as and provides a mechanical coding that engages with a complementary shaped mechanical counter-coding on the inside of the receptacle 72 of the sidewall 71 of the device 46.

[0118] Two examples of different coding elements 54, 54' are evident from Fig. 6. On the left side of Fig. 6, a first cartridge assembly 100 is shown, which includes a cartridge holder 20 and a cartridge 11 or drug container 10 disposed therein. The cartridge assembly 100 includes a retainer part 30 connected with a container assembly 120. The container assembly 120 includes a connector part 40 and a drug container 10.

[0119] The first cartridge assembly 100, and therefore the first cartridge holder 20, includes a first connector part 40 featuring a first fastening element 53 and a first coding element 54. The first connector part 40 includes a first distal connector 43 for interconnecting with the proximal end 33 of the retainer part 30.

[0120] 6, a second cartridge holder 20' is shown forming a second cartridge assembly 100'. The second cartridge assembly 100' includes a second container assembly 120'. The second container assembly 120' includes a second connector part 40' and a second medicament container 10 (not shown). The second medicament container may be distinguished from the first medicament container by its size, its geometric shape, and / or by the type and / or concentration of medicament therein.

[0121] The first container assembly 120 and the second container assembly 120 ′ form or comprise a kit of container assemblies 150 .

[0122] The second connector part 40' is thus distinguished from the first connector part 40. As shown, the coding element 54' of the second connector part 40' is in a different position relative to the fastening element 53 as compared to the position of the coding element 54 relative to the fastening element 52 of the first connector part 40. Thus, the proximal connector 59' of the second connector part 40' can only or exclusively be connected to a second type of device body 6, whereas the first connector part 40 with the first proximal connector 59 can only and exclusively be connected to a first type of device body 6. The first and second device bodies are distinguished from each other by their counter coding elements 74.

[0123] Here, the counter coding element of the second device body is provided in a different relative position to the counter fastening element 73 compared to the counter coding element 74 and the counter fastening element 73 of the first device body 6 .

[0124] As can be further seen from Figures 4, 5, 8 and 9, the connector part 40 includes a receptacle 62 sized and shaped to receive the proximal end of the medicament container 10, where the connector sidewall 41 circumferentially surrounds the receptacle 62. The receptacle 62 is defined proximally, and thus longitudinally, by a stop surface 57 provided on a flange portion 58 that projects radially inwardly from the inside of the connector sidewall 41. As can be seen from Figures 7 and 10, for example, the radially inwardly extending flange portion 58 with its distally facing stop surface 57 is configured to longitudinally abut the proximal end of the barrel 12 and thus the sidewall 13 of the cartridge 11 or medicament container 10.

[0125] Towards the distal end, the medicament container 10 may abut longitudinally with an end wall 37 of the retainer part 30. The end wall 37 may form the distal end 24 of the cartridge holder 20. The end wall 37 may extend radially inwardly from the cylindrical portion of the connector 25. The end wall 37 may include a radially inwardly extending flange section featuring a proximally facing stop surface 38. The stop surface 38 may abut longitudinally with the distal end of the medicament container 10, for example with the seal 18 or septum retainer 19 shown in FIG. 7, FIG. 11, or FIG. 14.

[0126] As is evident from Figures 7, 11 and 14, the drug container 10 may be fixed longitudinally in the cartridge receiving space 28. The drug container 10 may abut longitudinally distally against the end wall 37 and thus against the proximally facing stop surface 38. The drug container 10 may further abut longitudinally against the distally facing stop surface 57 of the flange portion 58 of the connector part 40. The interconnection between the connector part 40 and the retainer part 30 is tension- and pressure-stable. In this way, when the final assembled configuration is reached in which the fastening element 35 engages with the counter-fastening element 45 and thus the catch element 46 engages with the recess 36, the drug container 10 may be clamped or at least held firmly in the cartridge receiving space with respect to the longitudinal direction (z).

[0127] As further shown in Figures 4 and 14-17, the connector part 40 further includes a receptacle fastener 50. The receptacle fastener 50 includes a first fastening rib 51 and a second fastening rib 52. Similar to the counter fastening element 45, the fastening ribs 51, 52 are located on opposite sides of the inside of the connector side wall 41. As further shown in Figure 4, the fastening ribs 51, 52 may project in the distal direction 2 from the annular end surface 44 of the connector side wall 41. The fastening ribs 51, 52 also extend radially inward from the tubular connector side wall 41. The fastening ribs 51, 52 may project radially inward into the cartridge receiving space 28.

[0128] As is particularly evident from Fig. 9, the radial distance between the oppositely located first and second fastening ribs 51, 52 is smaller than the radial distance between the oppositely located counter fastening elements 45, and therefore smaller than the radial gap between the oppositely located catch elements 46. The radial distance between the first and second fastening ribs 51, 52 corresponds equally to, or even slightly smaller than, the outer distance or outer diameter of the barrel 12 at its proximal end. In this way, the barrel 12 of the drug container 10 can be fitted into the receptacle 62, thereby engaging the inwardly facing engagement surfaces 63 of the first and second fastening ribs 51, 52.

[0129] Here, the exterior surface of the sidewall 13 of the barrel 12 may frictionally engage with the interior surfaces of the first and second fastening ribs 51, 52, and thus the engagement surface 63. In this manner, the medication container 10 may be pre-assembled and fastened to the connector part 40, thereby forming, for example, the container assembly 120 shown in FIG. 5. The friction fit between the container fastener 50 and the barrel 12 may be such that a consumer or patient cannot exert a force large enough to remove the medication container 10 from the container fastener. The pull-out force may be greater than what the average person can exert.

[0130] Thus, the container fastener 50 may be in a press-fit configuration with the drug container 10. In some examples, the container assembly, i.e., the drug container 10 pre-mated with the connector part 40, may be commercially available as a disposable unit. Thus, the retainer part 30, which is removably connectable to the connector part 40, may be embodied as a reusable component.

[0131] As particularly shown in Figures 8 and 9, a radial gap 61 is provided between the inside of the counter fastening element 45 and the outside of the side wall 13 of the barrel 12 of the medicament container 10. The radial extent of this gap 61 is typically slightly greater than the radial distance required to disengage the catch element 46 from the recess 36. In this way, with the cartridge 11 or medicament container 10 assembled in the cartridge holder 20, it is generally possible to bias the projection 47, and thus the catch element 46, radially inwardly to such an extent that the projection 47 is disengaged from the recess 36, thereby disengaging and releasing the connector 43 from the fastening element 35 of the proximal end 33 of the retainer part 30.

[0132] Typically, as particularly shown in figure 13, the catch element 46 is provided with a predetermined breaking structure 49 embodied as a structural weakening. By pressing the projection 46 and thus the catch element 46 radially inwards, for example by inserting a suitably sized tool from the outside into the recess 36, the nose or projection 47 of the catch element 46 may break and collapse, destroying and / or disabling the function of the counter-fastening element 45.

[0133] When the catch element 46 is transitioned from the fastening configuration, e.g., as shown in Figures 11-13, to the release configuration, e.g., by pushing the catch element 46 radially inward, the catch element 46 disintegrates into at least two parts and becomes substantially inoperable.

[0134] In this way, the connector part 40, which may still be connected and fastened to the medicament container 10, can no longer be used. The medicament container 10 together with the connector part 40 is then discarded in its entirety. The user must then be provided with a new container assembly 120, i.e. a new medicament container 10 fitted and provided with a new connector part 40. The connector part 40 and the medicament container 10 can be provided in a pre-assembled state. The connector part 40 and the medicament container 10 need to be connected with the reusable retainer part 30, thereby forming or constituting a new or repaired cartridge holder 20. The new cartridge holder 20 (i.e. with a new cartridge 11 and a new connector part 40) can then be reattached to the reusable device body 6 and thus to the reusable drive mechanism 7 in a conventional manner.

[0135] The proximal end 33 of the retainer part 30 includes a certain receptacle 32 sized and shaped to receive the fastening ribs 51, 52 and the counter fastening element 45 of the connector part 40. For accurate alignment of the connector part 40 with the retainer part 30, the receptacle 32 provided at the proximal end of the retainer side wall 31 includes at least one recess 39 embodied as a longitudinal groove, configured and sized to receive the fastening rib 51, for example shown in Fig. 9. Here, the groove-like recess 39 provides a mechanical guiding function for the longitudinally extending fastening ribs 51, 52.

[0136] The fastening ribs 51, 52 which may protrude longitudinally from the counter fastening element 45 may be aligned with complementary shaped grooves or recesses 39 on the inside of the retainer side wall 31, thereby providing mounting aids for inserting the fastening ribs 51, 52, and thus the counter fastening element 45, into the receptacle 32 until the final assembled configuration is reached.

[0137] In this regard, the fastening ribs 51, 52 serve a dual or two-fold function. First, the fastening ribs 51, 52 provide for fastening of the drug container 10 to the connector part 40. Second, the fastening ribs 51, 52 enable and facilitate proper alignment and engagement of the distal connector 43 and the fastening element 35 during insertion of the proximal end 33 of the retainer part 30 into the receptacle 32.

[0138] In Fig. 18 a flow chart of a method for assembling an injection device 1 or replacing a medicament container 10 is shown. In a first step 200, a medicament container 10, e.g. a cartridge 11, is connected with a connector part 40, where the connector part 40 is provided as a separate component. A container fastener 50 of the connector part 40 receives a proximal end of the medicament container 10, where the proximal end of the barrel 12 may be clamped or frictionally engaged with diametrically opposed fastening ribs 51, 52.

[0139] In a next step 202, the container assembly 120 formed by the medicament container 10 and the connector part 40 is inserted into the retainer part 30. Here, the distal or main part of the medicament container 10 protruding distally from the connector part 40 is inserted in a longitudinal distal direction 2 into the interior of the retainer part 30 through the receptacle 32. In a next step 204, a mechanical connection is established between the proximal end 33 of the retainer part 30 and the distal connector 43 of the connector part 40. After this step, a cartridge assembly 100, i.e. a cartridge holder 20, is provided which is readily equipped with a medicament container 10. In a next step 206, the cartridge holder 20, and thus the cartridge assembly 100, is connected to the distal end 79 of the device body 46, thereby forming or constituting an injection device 1, which is thus ready to set and expel one or several doses of medicament 16. For this purpose, the proximal connector 59 of the connector part 40 is connected and / or fixed to the distal end 79 , in particular to a counter fastening element 73 of the device body 6 . [Explanation of symbols]

[0140] 1. Injection Device 2 Distal direction 3 Proximal direction 4 Piston rod 5 Pressure Components 6 Device body 7 Driving mechanism 8 Dispensing member 9. Trigger 10. Drug containers 11 Cartridge 12 barrels 13 Side wall 14 Main part 15 Piston 16 Drugs 17 Discharge end 18 Seal 19 Septum retainer 20 Cartridge holder 21 Side wall 22 Connection end 23 Proximal end 24 Distal end 25 Connectors 26 Aperture 27 Threaded Section 28 Cartridge storage space 29 Main Unit 30 Retainer parts 31 Retainer side wall 32 Receptacle 33 Proximal end 34 End face 35 Fastening elements 36 Recess 37 End Wall 38 Stop surface 39 Recess 40 Connector parts 41 Connector side wall 42 Insert 43 Distal Connector 44 End face 45 Counter fastening element 46 Catch-up elements 47 Protrusion 48 Beveled Edge 49 Predetermined breaking structure 50 Container fastener 51 Fastening rib 52 Fastening rib 53 Fastening Elements 54 Coding Elements 55 Fastening protrusion 56 Coding protrusion 57 Stop surface 58 Flange part 59 Proximal Connector 60 End face 61 Gap 62 Receptacle 63 Engagement surface 64 Flange part 68 Protective Cap 71 Side wall 72 Receptacle 73 Counter fastening elements 74 Counter Coding Elements 79 Distal end 100 Cartridge Assembly 120 Container Assembly 150 Vessel Assembly Kit

Claims

1. A cartridge holder (20) for an injection device (1), comprising: an elongate body (29) extending in a longitudinal direction (z), said elongate body (29) including a distal end (24) and a proximal end (23) opposite said distal end (24), said elongate body (29) enclosing a cartridge receiving space (28) for receiving a medicament container (10); a retainer part (30) including a retainer side wall (31) surrounding a distal portion of said cartridge receiving space (28), said retainer part (30) including a proximal end (33); a connector part (40) including a connector side wall (41) and a distal connector (43) configured to connect to the proximal end (33) of the retainer part (30), the connector part (40) including a proximal connector (59) configured to connect to a distal end (79) of a device body (6) of the injection device (1), the device body (6) being configured to accommodate a drive mechanism (7) that operatively engages with the medicament container (10); A cartridge holder (20).

2. 2. The cartridge holder (20) of claim 1, wherein the connector side wall (41) forms a longitudinal extension of the retainer side wall (31) when the connector part (40) is connected to the retainer part (30).

3. The cartridge holder (20) of claim 2, wherein the connector side wall (41) and the retainer side wall (31) are flush in the longitudinal direction (z).

4. A cartridge holder (20) as described in claim 2 or 3, wherein an inner surface of the connector side wall (41) is flush with an inner surface of the retainer side wall (31) and / or an outer surface of the connector side wall (41) is flush with an outer surface of the retainer side wall (31).

5. The cartridge holder (20) of any one of claims 1 to 4, wherein the connector part (40) includes a flange portion (58) extending radially inward from the connector side wall (41), the flange portion (58) including a distally facing stop surface (57) configured to abut against a proximal end of the drug container (10).

6. A cartridge holder (20) as described in any one of claims 1 to 5, wherein the proximal end (33) of the retainer part (30) includes a proximal end face (34) of a shape complementary to a distal end face (44) of the connector part (40), and the proximal end face (34) abuts longitudinally against the distal end face (44) when the connector part (40) is connected to the retainer part (30).

7. A cartridge holder (20) as described in any one of claims 1 to 6, wherein the distal connector (43) of the connector part (40) and the proximal end (33) of the retainer part (30) are configured to form at least one of a tension-stable mechanical connection and a pressure-stable mechanical connection.

8. The cartridge holder (20) of any one of claims 1 to 7, wherein the connector part (40) comprises a container fastener (50) configured for mechanical engagement with a proximal end of the medicament container (10).

9. The cartridge holder (20) of claim 8, wherein the container fastener (50) is configured to non-detachably connect to the medication container (10).

10. The cartridge holder (20) of claim 8 or 9, wherein the container fastener (50) includes a first fastening rib (51) and a second fastening rib (52) on opposite sides of the cartridge receiving space (28), the first fastening rib (51) and the second fastening rib (52) being configured to frictionally engage with the barrel (12) of the drug container (10).

11. 11. The cartridge holder (20) of claim 10, wherein at least one of the first fastening rib (51) and the second fastening rib (52) protrudes distally from a distal end face (44) of the connector part (40) and engages with a complementarily shaped recess (39) in the retainer part (30) when the connector part (40) is connected to the retainer part (30).

12. A cartridge holder (20) according to any one of claims 1 to 11, wherein one of the proximal end (33) and the distal connector (43) includes a fastening element (35) having a shape complementary to a counter fastening element (45) of the other of the proximal end (33) and the distal connector (43).

13. The cartridge holder (20) of claim 12, wherein one of the fastening element (35) and the counter fastening element (45) includes a recess (36), and the other of the fastening element (35) and the counter fastening element (45) includes a catch element (46) configured to engage with the recess (36).

14. The cartridge holder (20) of claim 13, wherein the catch element (46) of one of the retainer part (30) and the connector part (40) extends longitudinally and is configured to engage with the recess (36) provided in the connector side wall (41) or the retainer side wall (31) of the other of the retainer part (30) and the connector part (40).

15. A cartridge holder (20) as claimed in any one of claims 1 to 14, wherein the distal connector (43) includes a predetermined breaking structure (49) configured to break the distal connector (43) apart when a user attempts to disengage the distal connector (43) from the proximal end (33) of the retainer part (30).

16. The cartridge holder (20) of any one of claims 1 to 15, wherein the connector part (40) comprises a mechanical coding element (54) for mechanically engaging with a complementarily shaped mechanical counter coding element (74) of the device body (6).

17. A cartridge assembly (100) comprising a cartridge holder (20) according to any one of the preceding claims and further comprising a drug container (10) disposed within the cartridge receiving space (28).

18. An injection device (1) for setting and injecting a dose of a drug (16), comprising: a device body (6), - a drive mechanism (7) disposed within said device body (6) and configured to operatively engage a medicament container (10) containing said medicament (16); one of a cartridge holder (20) according to any one of claims 1 to 16 and a cartridge assembly (100) according to claim 17 connectable or connected to a distal end (79) of said device body (6); An injection device (1).

19. A container assembly (120) for an injection device (1), comprising: a medicament container (10) comprising a barrel (12) filled with a medicament (16); a connector part (40) of a cartridge holder (20) according to any one of claims 1 to 13, said connector part (40) being connected or fixed to said medicament container (10); A container assembly (120).

20. A container assembly kit (150), comprising: A first container assembly (120) according to claim 19, said first container assembly (120) comprising a first medicament container (10) and a first connector part (40) connected or fixed to said first medicament container (10) and comprising a first proximal connector (59) and a first distal connector (43); A second container assembly (120') according to claim 19, said second container assembly (120') comprising a second medicament container (10') and a second connector part (40') connected or fixed to said second medicament container (10') and comprising a second proximal connector (59') and a second distal connector (43'); Including, - said first drug container (10) is distinct from said second drug container (10') and said first proximal connector (59) is distinct from said second proximal connector (59'); A container assembly kit (150).

Images