Cartridge assembly for drug delivery device and drug delivery device

Abstract

To provide a cartridge assembly for a drug delivery device.SOLUTION: A cartridge assembly for a drug delivery device includes: a cartridge 301 storing a drug; and a cartridge holder for defining a cartridge storage section in the inside. The cartridge 301 is arranged inside the cartridge storage section. The cartridge holder includes a distal region 317 and a main body region 318. A needle connector 319 is arranged in a distal end of the distal region 317. The cartridge assembly further includes: a fixation function 322 arranged in the distal region 317; and a region 350 having a mechanical rigidity reduced more than rigidity of the main body region 318. The region 350 is integrated with the distal region 317 and is arranged between the needle connector 319 and the fixation function 322. When the cartridge 301 is moved in a proximal direction, a generated load is transmitted from the cartridge 301 to the fixation function 322 and to the main body region 318 in the proximal direction.SELECTED DRAWING: Figure 4

Description

[Technical Field]

[0001] The present disclosure relates to a cartridge assembly, particularly a cartridge assembly for a drug delivery device, preferably an injection device and / or a pen-type device such as a pen-type injector. Further, the present disclosure relates to a drug delivery device including a cartridge assembly. [Background technology]

[0002] In a typical drug delivery device, a single drive mechanism that can be housed within the housing of the drug delivery device is used with several cartridges or ampoules to dispense the drug contained in the cartridges or ampoules from the device, and typically a cartridge holder of the device is releasably coupled to the housing so that the cartridge holder can be removed from the housing to replace a used cartridge. To do so, the cartridge holder is decoupled from the housing, the used cartridge is removed from the holder and replaced with a new cartridge, the new cartridge is inserted into the cartridge holder, the cartridge holder is reattached to the housing, and the device is ready to be used again to dispense drug from the new cartridge.

[0003] However, this type of device presents several risks. For example, a cartridge containing a drug for which the mechanism of the drug delivery device is not specifically designed, i.e., the wrong drug, may be inserted into the cartridge holder, and the user may not realize that they have placed the wrong drug cartridge into the cartridge holder. This mistake could be fatal to the user, and is likely to occur because cartridges containing different drugs are typically very similar. Furthermore, cartridges run the risk of being damaged if sold as separate items, especially since standard cartridges are typically glass cartridges. Summary of the Invention [Problem to be solved by the invention]

[0004] The present invention relates to the design of a cartridge locking system for use in a drug delivery device.

[0005] It is an object of the present disclosure to provide an improved cartridge assembly for a drug delivery device, and / or further improvements or configurations related to the cartridge assembly. These and potentially other objects are solved by the present disclosure, particularly by the subject matter of the independent claims. Advantageous embodiments and refinements are the subject of dependent claims. One particular object of the present disclosure is to increase the stability of a cartridge clamped in a cartridge holder against attempts to remove the cartridge from the holder. As will become apparent from the following description, this can be achieved by increasing the amount of load traveling along one or more load paths, particularly within the cartridge holder, and / or by reducing the amount of load traveling along a load path that tends to cause radially outward deflection of a locking feature, particularly when an attempt is made to remove the cartridge from the cartridge holder. [Means for solving the problem]

[0006] One aspect of the present disclosure relates to a cartridge assembly, particularly a cartridge assembly for a drug delivery device such as a pen device and / or an injection device. Another aspect relates to a drug delivery device. The drug delivery device conveniently includes a cartridge assembly as described herein above and below and a housing.

[0007] The cartridge assembly can be releasably locked to a housing, within which can be held a drive mechanism, or at least one or more elements thereof, such as a piston rod, preferably designed to drive a dispensing action to dispense the drug from the cartridge.

[0008] The cartridge assembly includes a cartridge. The cartridge assembly includes a cartridge holder. The cartridge holder can define an internal cartridge storage section. The cartridge storage section can be circumferentially delimited by the cartridge holder, particularly by one or more members thereof. The cartridge is conveniently disposed within the cartridge storage section. The cartridge assembly further includes a locking feature. The locking feature can conveniently be positioned to abut or abut a cartridge face, particularly a radially oriented surface, of the cartridge. The locking feature can be positioned to prevent removal of the cartridge from the cartridge holder. Thus, the cartridge can be permanently locked within the cartridge holder. The locking feature can be positioned to prevent removal of the cartridge from the cartridge holder through an opening in the cartridge holder, preferably a proximal opening. This opening can be the opening through which the cartridge is inserted into the cartridge holder, for example, when assembling the cartridge assembly. The cartridge face can be a proximal face facing away from the dispensing end of the cartridge.

[0009] The cartridge holder includes at least two exterior regions. These exterior regions can include a distal region and a main body region, or can be a distal region and a main body region. The distal region can be located closer to the dispensing end of the cartridge than the main body region. A distal end wall of the cartridge holder can define a distal boundary of the distal region. A needle connector is located at the distal end of the distal region. The main body region can hold the main body portion of the cartridge. The distal region can hold the head portion of the cartridge therein.

[0010] The locking feature is located in the distal region. The cartridge holder includes a region having reduced mechanical stiffness relative to the stiffness of the main body region. This region is integrated into the distal region and located between the needle connector and the locking feature. Therefore, when the cartridge is moved proximally, the load generated is transferred proximally from the cartridge to the locking feature and then to the main body region. This region can be positioned around the circumference of the distal region, the main body region, or a shoulder region positioned between the distal region and the main body region. In contrast to the known technical solution shown in FIGS. 3A and 3B, the region having reduced mechanical stiffness according to the present disclosure can be fixed in position. The region having reduced mechanical stiffness can be positioned relative to the shoulder region and / or the distal region. It will be understood that by fixing this region in position, the region having reduced mechanical stiffness remains in the position where it is positioned relative to the shoulder region and / or the distal region. In contrast, the flexible arms shown in FIGS. 3A and 3B can bend radially outward.

[0011] It is advantageous to keep load transmission to the distal region as small as possible or to avoid it altogether. Due to the integration of a region with reduced mechanical stiffness in the distal region, a continuous mechanical coupling of the locking feature to the distal region of the cartridge holder in the circumferential direction can be achieved, and access to, e.g. tampering with, the locking feature can be prevented.

[0012] During assembly, the locking features can flex outward more easily due to the area of ​​reduced stiffness, allowing the cartridge septum retainer to move into the assembled position. In situations where the cartridge is pushed proximally relative to the cartridge holder, such as occurs if the subassembly is dropped or if a user attempts to remove the cartridge from the cartridge holder, the load path of the locking features is changed proximally. The locking features have a profile that allows for easy and straightforward assembly of the cartridge by applying an axial load to the cartridge.

[0013] The cartridge contains a drug or medication. The cartridge includes a dispensing end through which the drug or medication can be dispensed from the cartridge. The dispensing end of the cartridge may be referred to as the distal end.

[0014] In these scenarios, altering the load path increases the tendency of the fixation features to flex inward and decreases the tendency of the features to flex outward, thereby increasing the fixation strength provided by the fixation features.

[0015] Furthermore, the present disclosure allows for repeatable and reliable assembly of the cartridge into the cartridge holder by distal insertion of the cartridge and application of distal-only force to the cartridge provided by standard cartridge assembly equipment, thereby robustly retaining the cartridge within the cartridge holder through use and foreseeable abuse scenarios.

[0016] The region having reduced mechanical stiffness can include a groove or aperture. Providing a groove has the advantage of closing the cartridge holder against the environment. The shape and depth of the groove determine the stiffness of the material in this region. Larger, deeper grooves provide reduced stiffness compared to smaller, shallower grooves. Further reduced stiffness can be achieved by apertures that include complete removal of material across their thickness, including the aperture. The groove or aperture can have a rectangular or rounded rectangular shape. The groove or aperture can be aligned adjacent to the main body portion. The cartridge holder can include a shoulder region disposed between the distal region and the main body region. In this case, the groove or aperture can be disposed adjacent to the shoulder region in the distal direction.

[0017] The locking feature comprises a locking surface, in particular a radially oriented surface. The locking surface is conveniently arranged to abut or abut a cartridge surface, in particular a radially oriented surface, of the cartridge. The locking surface can be arranged to prevent removal of the cartridge from the cartridge holder. Thus, the cartridge can be permanently locked in the cartridge holder.

[0018] The securing surface can be positioned to prevent removal of the cartridge from the cartridge holder through an opening in the cartridge holder, preferably a proximal opening. This opening can be the opening through which the cartridge is inserted into the cartridge holder, for example, when assembling the cartridge assembly. The cartridge face can be a proximal face facing away from the dispensing end of the cartridge. The securing surface can face toward the cartridge face.

[0019] The fixing feature, particularly the fixing surface, can abut against the cartridge, particularly the cartridge face, or can be arranged to abut against the cartridge, particularly the cartridge face, or can mechanically cooperate with the cartridge, particularly the cartridge face, to secure the cartridge in the cartridge holder. The cartridge face can be arranged between the dispensing end of the cartridge and the end opposite the dispensing end. In particular, the cartridge face can be a surface different from the end face of the cartridge, and two end faces, such as a distal end face and a proximal end face, define the cartridge in its main longitudinal extent. The fixing feature can be integrated into the cartridge holder. The fixing feature can be, for example, a snap function or a clip function.

[0020] In one embodiment, the locking feature axially clamps the cartridge within the cartridge holder. In particular, the locking feature can prevent proximal movement of the cartridge relative to the cartridge holder. The locking surface can permanently abut the cartridge face. In particular, the cartridge can be axially fixed within the cartridge holder by the locking feature. Distal movement of the cartridge relative to the cartridge holder can be prevented by a proximal face of the cartridge holder, for example, an inner surface of the distal end wall. The proximal face can be distally offset from the locking surface. The proximal and locking surfaces can be adjusted such that a portion of the cartridge, such as a head portion, is preferably tightly received between the locking and proximal surfaces. If a portion of the cartridge is tightly received between these surfaces, an additional resilient biasing member, such as a cartridge biasing spring, that biases the cartridge distally relative to the cartridge holder to offset mechanical play between the components can be avoided. Alternatively, the cartridge is axially movable relative to the cartridge holder, for example, because the proximal and locking surfaces are separated by a distance greater than the axial extension of the portion of the cartridge received therebetween. In this case, a preferably elastic biasing member can be provided, for example, in the drug delivery device, which biases the cartridge distally relative to the cartridge holder, i.e., maintains the distal face of the cartridge in contact with the cartridge holder, e.g., the proximal face of the cartridge holder. In this case, the cartridge face can be arranged at a distance from the fixed face. The biasing member can be a spring washer or another elastically deformable member. The biasing member can abut, i.e., directly contact, the cartridge, or can transmit a force to the cartridge indirectly, for example via a spacer. The biasing member can maintain the distance between the fixed face and the cartridge face.

[0021] The cartridge may be a glass cartridge.

[0022] In one embodiment, the locking features protrude, in particular radially, from the inner wall of the cartridge holder. In this way, the inner diameter of the cartridge holder can be reduced to a value below the outer diameter of the cartridge, in particular the head portion of the cartridge. The locking features can be oriented radially or oblique to the radial and axial directions.

[0023] In one embodiment, the locking surface includes a height facing the cartridge face. The height can be located at an edge or at the center of the locking feature. The cartridge face can include a convex shape, preferably with its maximum located at the center. The locking surface contacts the cartridge face at the center of the locking surface.

[0024] In one embodiment, the locking surfaces can be inclined and / or angled relative to the axial and radial directions. The locking surfaces are oriented relative to the cartridge face such that the surfaces face toward each other and are not parallel to each other. The locking surfaces can contact the cartridge at the radially inner edges of the locking features.

[0025] In one embodiment, the fixation feature includes a region having a reduced thickness compared to the thickness of the main body region, which can be achieved by removing material from its radially outermost portion, thereby reducing stiffness in this region and making the fixation feature more flexible.

[0026] In one embodiment, the region of reduced mechanical stiffness overlaps the fixation feature angularly, axially, and / or radially.

[0027] In one embodiment, the region with reduced mechanical stiffness is restricted to a region distal to the fixation feature.

[0028] In one embodiment, a portion or the entire region of reduced mechanical stiffness is radially outwardly offset from the fixation feature and can be connected to another portion of the region of reduced mechanical stiffness that is distally offset from the fixation feature, such as an opening.

[0029] In one embodiment, the cartridge receiving section includes at least three internal regions: a first region, a locking feature region, and a second region. The locking feature is conveniently located within the locking feature region. The locking feature region can be located between the first region and the second region, particularly when viewed axially. The inner diameter, preferably the smallest inner diameter or clear span, of the cartridge holder within the locking feature region is preferably smaller than the inner diameter, preferably the smallest inner diameter or clear span, within the first region and the inner diameter, preferably the smallest inner diameter or clear span, within the second region. The first region and the second region can have different and / or constant inner diameters or clear spans. Accordingly, the locking feature can define a region of reduced inner diameter. As already explained above, this inner diameter is preferably smaller than the outer diameter of the head portion of the cartridge. The first region can be the region of the cartridge holder where the head portion is to be located, and the second region can be the region where the main body portion of the cartridge is to be located. The axial extensions of the first and second regions may be different. The axial extension of the second region may be greater than the axial extension of the first region. A fixation surface may define a proximal boundary of the first region. Fixation features can be particularly easily implemented by injection molding if they are located within a region where the internal diameter of the cartridge holder changes. Core pins used during injection molding to define each internal region of the cartridge holder within the molding tool require only slight adjustments so that fixation features can be integrated into the cartridge holder within the region where pins with different diameters intersect. Injection molding is particularly suitable for large volumes.

[0030] In one embodiment, the cartridge receiving section of the cartridge holder includes a distal interior region. The distal interior region can be located distally relative to the fixing surface of the fixing feature. That is, the distal interior region can be a region of the interior of the cartridge holder where the head portion of the cartridge is to be positioned within the cartridge assembly when the cartridge is guided into the cartridge holder. The cartridge guiding feature can be located within the distal interior region. The cartridge guiding feature can protrude radially from an inner wall of the cartridge holder, the inner wall being located within the distal interior region. The cartridge guiding feature can be configured to cooperate with the cartridge, e.g., a septum retainer, to move the cartridge, particularly its head portion, radially relative to the fixing surface. The cartridge guiding feature can be angularly offset from the fixing feature and / or the fixing surface. The cartridge guiding feature can be located opposite the fixing feature. When multiple fixing features are provided, the number of cartridge guiding features can be equal to or less than the number of fixing features. However, regardless of the number of fixing features, one cartridge guiding feature is sufficient. The cartridge guiding feature can be distally offset from the fixing feature. In other words, there can be an axial gap between the cartridge guiding feature and the fixing surface. The distal interior region is conveniently designed to receive the head portion of the cartridge. Thus, the distal interior region can correspond to the first region of the cartridge holder discussed above. The distance by which the cartridge guiding feature is distally offset from the fixing surface and / or fixing feature can be equal to or greater than the axial dimension or extension, e.g., thickness, of the septum of the cartridge. Alternatively or additionally, the distance by which the cartridge guiding feature is distally offset from the fixing surface and / or fixing feature can be less than the axial dimension or axial extension of the head portion of the cartridge. The head portion can include the head portion of the cartridge body, a septum, and a septum retainer, such as a metal sleeve, that permanently connects the septum to the cartridge body.By providing a guide feature at such a distal offset, the septum of the cartridge can pass through the fixation feature of the fixation surface, and then the cartridge can cooperate with the guide feature arranged to move the cartridge radially relative to the fixation surface, thereby increasing the overlap between the fixation surface and a cartridge surface arranged to interact with the fixation surface and hold the cartridge in the cartridge holder.

[0031] The external distal region can correspond to a first internal region, and the main body region can correspond to a second internal region, relative to an axial position along the extension of the cartridge holder from the proximal opening to the distal end. The outer diameter of the cartridge holder can be smaller in the distal region than in the main body region. The fixation surface and / or fixation feature can be located at an axial position, particularly when viewed along the cartridge holder. The axial position can be located in the distal region of the cartridge holder. Accordingly, the fixation surface can be located in an interior of the cartridge holder at a position overlapping the distal region, which can have a reduced outer diameter. Accordingly, the fixation feature region can at least partially axially overlap the distal region.

[0032] In one embodiment, one of the first region or the second region includes a distal inner region disposed distally relative to the locking feature, the distal inner region including two regions with two different inner diameters, the region with the smaller of the two different diameters disposed distally relative to the region with the larger inner diameter. The cartridge can be inserted distally into the cartridge holder through an opening located at the proximal end of the cartridge. As the cartridge moves distally, it contacts the locking feature, which is located in the region of the cartridge holder with the larger inner diameter. As the cartridge is moved further distally, it reaches the region with the smaller inner radius, and therefore the outer surface of the cartridge has tighter contact with the inner wall of the cartridge holder than the region with the larger diameter.

[0033] The cartridge can have a main body portion and a head portion connected via a neck portion, and the head portion can have a reduced diameter compared to the main body portion and / or the neck portion. The main body portion can be cylindrical. The dosing end or opening of the cartridge can be disposed within the head portion. The dosing end or opening can be closed, for example, by a septum, preferably pierceable and / or resilient. The septum can be pierced by a needle to provide fluid communication between the interior and exterior of the cartridge. The septum can be fastened to the cartridge body, for example, of a glass cartridge. For example, the septum can be fastened to the cartridge body by a septum retainer, for example, a metal, such as a sleeve and / or a metal sleeve. The cartridge holder can have an opening that defines the cartridge holder in a proximal direction. In a distal direction, the cartridge holder can be defined by a distal end wall. The distal end face of the cartridge can be positioned to abut against an inner proximal face of the cartridge holder. The proximal face can be located on an inner surface defined by the distal end wall. In other words, the cartridge cannot be moved relative to the cartridge holder in the distal direction. The locking feature can permanently lock the cartridge in the cartridge holder. Preferably, without the locking feature, the cartridge could be removed from the cartridge holder, for example through the proximal opening. The locking surface can be the distal surface of the locking feature, i.e. the surface facing in the distal direction, for example the surface facing away from the proximal opening of the cartridge holder.

[0034] Because the fixing feature is integrated into the cartridge holder, for example forming the fixing feature unitarily with the cartridge holder body, it can be integrated into the normal manufacturing process of the cartridge holder, for example by injection molding, and there is no need to make a separate fixing member to secure the cartridge within the cartridge holder or to perform a separate assembly step to appropriately position the fixing member relative to the cartridge and cartridge holder.

[0035] In one embodiment, the outer surface or wall of the cartridge holder, e.g., a side wall of the cartridge holder, extends along and / or covers the entire locking feature, e.g., axially and / or angularly or azimuthally. In other words, the cartridge holder can be radially closed, e.g., by a side wall, preferably along the entire angular or azimuthal extension of the locking feature and / or preferably along the entire axial extension of the locking feature. In contrast to locking features that angularly or axially overlap openings in the cartridge holder, such a configuration is easier to manufacture, e.g., by injection molding. Because the locking feature can be provided in an area of ​​the cartridge holder that does not have radially extending openings, the locking feature is not easily accessible from the outside. If the locking feature overlapped or was defined by such openings, the locking feature would be easily accessible from the outside. This helps prevent manipulation of the cartridge assembly.

[0036] Alternatively or cumulatively to the region of reduced stiffness, the cartridge holder includes a region of increased mechanical stiffness, which may be located proximally adjacent the fixation surface and reduces the radial flexibility of the cartridge holder in that region, thus preventing proximal movement of the cartridge. The region of increased mechanical stiffness may be located on an inner or outer wall of the cartridge holder.

[0037] In one embodiment, the cartridge holder is a unitary member. In particular, the cartridge holder can be an injection molded member. The cartridge holder, including the distal region and the main body region, can then be formed as a single piece. Although the cartridge holder is formed as a single piece, the cartridge holder can nevertheless have an integrated locking feature that cooperates with the proximal surface of the cartridge.

[0038] In one embodiment, the fixation surface is a flat surface.

[0039] In one embodiment, the cartridge holder has a distal end wall or face. The distal end wall can be positioned to abut the distal face of the cartridge. In particular, the proximal face of the distal end wall can be positioned to abut the distal face of the cartridge. The distal end wall can extend angularly, in particular around the main longitudinal axis. The end wall can have or define at least one opening, for example, only one opening or two or more openings. The opening can be bounded by angular faces of the distal end wall facing each other. The opening can be positioned radially and angularly overlapping the fixing surface or fixing feature. In particular, the fixing surface and the opening can be at corresponding radial and angular positions in the cartridge holder but at different axial positions. Conveniently, the fixing surface is offset proximally from the opening, in particular by a distance corresponding to or defined by the axial extension of the head portion.

[0040] In one embodiment, the angular and / or radial dimensions of the at least one opening determine the angular and / or radial dimensions of the fixation surface. Preferably, the angular and / or radial dimensions of the opening are equal to or greater than the angular and / or radial dimensions of the fixation surface. In this way, the fixation feature can be defined by a mold tool that is guided through a region of the mold designed to define the distal end of the cartridge holder until it reaches the position where the fixation feature is to be located.

[0041] An advantage of the opening in the distal end wall of the cartridge holder is that it increases the radial flexibility of the cartridge holder in the region of the opening and in the region extending axially from the opening toward and / or to the locking feature. This facilitates radial expansion of the cartridge holder when a cartridge is inserted into the cartridge holder while the cartridge cooperates with the rigid locking feature. When the head portion of the cartridge, for example, passes through the locking feature, the cartridge holder can regain its original, undeformed shape due to its unique inherent elasticity, and the locking surface can be positioned to abut against the cartridge surface and lock the cartridge within the cartridge retaining section.

[0042] In one embodiment, the locking feature is integrally formed with a portion or region of the cartridge holder. This portion or region may define or form at least a portion of the outer surface or outer contour of the cartridge holder. Thus, the locking feature may be integrated into an area or portion of the cartridge holder that defines the appearance of the cartridge holder.

[0043] Because the cartridge is conveniently permanently secured within the cartridge holder, the cartridge assembly can form one or a single unit of consumable material, i.e., the cartridge assembly, in its entirety, can be a disposable item, disposed of after the drug or medication within the cartridge has been dispensed and replaced with a new cartridge assembly.

[0044] If the cartridge is permanently locked in the cartridge holder by the locking feature, several advantages are obtained. For example, the cartridge is always protected by the cartridge holder when the user handles the cartridge assembly. The risk of the cartridge being damaged is then significantly reduced, in contrast to systems in which the cartridge in the holder needs to be replaced by the user. Conversely, in the proposed system, the entire cartridge assembly is replaced with a new one.

[0045] Furthermore, because the cartridge assembly includes not only the cartridge but also other elements such as the cartridge holder, it becomes easier to dedicate or code the cartridge to a particular drive mechanism or housing for a drug delivery device without having to specifically modify the cartridge design.

[0046] The personalization or coding can be achieved through features provided on the exterior of the cartridge holder, which can cooperate with features provided within the housing to allow a drive mechanism contained within the housing to couple a cartridge assembly to the housing if it matches the cartridge assembly or the drug or medication contained therein, or not if the wrong cartridge assembly is used. Alternatively or additionally, additional information regarding the contents of the cartridge, such as the name of the active pharmaceutical ingredient, trade name, etc., can be presented on the cartridge holder.

[0047] Because the cartridge face is located between the two ends of the cartridge, the disclosed concepts can be easily used with cartridges of different lengths. Accordingly, a set of cartridge assemblies having at least two cartridge assemblies can have two different cartridges of different lengths within the assembly.

[0048] In one embodiment, the cartridge face is positioned closer to the dosing end than the end opposite the dosing end, i.e., the proximal end. This facilitates locking cartridges of different lengths into the cartridge holder and / or provides a locking function in an area that is not easily accessible from the outside, i.e., an area farther from the proximal opening or end of the cartridge holder than the distal end of the cartridge holder. The cartridge face can be positioned farther from the proximal end by 2 / 3*L, 3 / 4*L, or 4 / 5*L, where L is the total length of the cartridge. The length of the cartridge can be defined or determined by the distance between the proximal end and the distal or dosing end of the cartridge.

[0049] In one embodiment, the cartridge face is a surface that axially bounds the head portion, particularly in the proximal direction. The cartridge face can extend circumferentially, for example flange-like, along the entire circumference of the cartridge.

[0050] In one embodiment, the end of the cartridge opposite the dispensing end is closed via a movable bung or stopper. When the bung or stopper is displaced within the cartridge toward the dispensing end, the drug or medication can be dispensed from the cartridge, provided that fluid communication is established between the interior and exterior of the cartridge, for example, by piercing a septum with a needle. The bung or stopper can be held within the main body portion of the cartridge. Accordingly, the main body portion of the cartridge can be freely designed with respect to length and / or diameter, etc., since the cartridge surface with which the fixing feature interacts can be located in the head portion. This facilitates fixing or fastening cartridges of different volumes within the cartridge holder. The bung or stopper conveniently seals and closes the cartridge proximally. The bung can be restricted to move within the main body portion, i.e., it cannot enter the neck portion and / or head portion.

[0051] In one embodiment, the locking features protrude, in particular radially, from the inner wall of the cartridge holder. In this way, the inner diameter of the cartridge holder can be reduced to a value below the outer diameter of the cartridge, in particular the outer diameter of the head portion of the cartridge. The locking features can be oriented radially or obliquely relative to the radial and axial directions.

[0052] In one embodiment, the cartridge holder is configured such that the locking feature can be radially displaced, preferably elastically, e.g. relative to the remainder of the cartridge holder. In this way, it is ensured that the cartridge, in particular a part of the head portion, can be guided over the locking feature, thereby deflecting or displacing the locking feature radially, e.g. outward. After the head portion has passed the locking surface, the locking feature can be displaced, expediently by its elasticity and / or inward, back to its original, undisplaced position, after which the cartridge can be clamped or locked in the cartridge holder.

[0053] In one embodiment, the cartridge holder includes a plurality of locking features with locking surfaces arranged to abut a preferably common cartridge surface of the cartridge, which may be distributed circumferentially, preferably evenly.

[0054] In one embodiment, the locking feature has a proximal surface. The proximal surface can face away from the locking surface. The proximal surface can be inclined and / or oblique relative to the axial and radial directions. The locking surface can be oriented radially. The inclined proximal surface of the locking feature guides the cartridge along the locking feature as the cartridge moves along the locking feature and facilitates displacement of the locking feature. The locking surface is preferably more inclined relative to the major axis of the cartridge holder than the proximal surface and can extend perpendicular to the axis.

[0055] In one embodiment, when the cartridge holder does not have an opening, the locking feature is located within the area of ​​the cartridge holder.

[0056] In one embodiment, in the area of ​​the locking feature, the cartridge holder is closed laterally, circumferentially and / or radially. Preferably, the cartridge holder is closed laterally and / or radially in the area of ​​the locking feature, such as along its entire circumference.

[0057] In one embodiment, the cartridge holder includes a needle connector, preferably in the distal region, that includes a coupling feature, such as a thread or other coupling means, suitable or configured for coupling a needle unit to the cartridge holder. The needle unit can include a needle hub and a needle held by the needle hub. The needle can be fastened to the needle hub and protrude distally from the hub. The proximal end of the needle can be designed to pierce a septum of the cartridge. The needle can be metal or steel, and the needle hub can be plastic. When the needle unit is coupled to the needle connector, the needle can extend through a distal opening of the cartridge holder toward the septum of the cartridge, piercing the septum and establishing fluid communication with the interior of the cartridge. A dose of a drug or medicament can then be dispensed from the interior of the cartridge through the needle.

[0058] In one embodiment, the distal end wall defines a central or needle opening. The distal end wall can extend circumferentially or angularly around the opening. The needle opening can be connected to an opening in or within the distal end wall. Accordingly, one continuous feature can be used to define both openings, i.e., the needle opening and the distal end wall opening corresponding to the location of the fixation surface, facilitating manufacturing of the cartridge holder via injection molding.

[0059] In one embodiment, the cartridge holder is an injection molded part and the injection gate is located at the distal end of the cartridge holder, particularly at the distal face of the distal end wall.

[0060] The septum is generally deformable, for example, elastically deformable. Accordingly, if radial forces are transmitted to the cartridge when the septum axially overlaps the locking feature, these forces may deform the septum and / or a septum retainer that may be disposed between the septum and the locking feature. Such forces may occur when the cartridge is guided past the locking feature and radially displaces the locking feature. Therefore, if these forces act on the septum, there is a risk that the cartridge may be damaged, for example, by deforming the septum retainer or by removing the septum from the cartridge body. Naturally, this is undesirable if these forces act on the septum or septum retainer, as this could severely damage the cartridge. Accordingly, the cartridge and cartridge holder are configured and adjusted relative to each other such that the locking feature is displaced only by a radial force exerted by the cartridge when the locking feature is positioned proximally offset from the septum relative to the cartridge, i.e., when the locking feature overlaps a portion of the cartridge body. Because the cartridge body has greater rigidity than the septum, the entire cartridge has greater rigidity in that area, greatly reducing the risk of damaging the cartridge.

[0061] In one embodiment, the cartridge holder includes only one locking feature or multiple locking features. When multiple locking features are present, they are conveniently uniformly distributed angularly and / or axially aligned. Each locking feature conveniently has an associated locking surface that can abut against the cartridge face. The angular extension of each locking feature or associated locking surface can be up to one of the following values: 20°, 15°, 10°.

[0062] In one embodiment, the distance between the cartridge face and the fixed face in the cartridge assembly can be zero, i.e., the surfaces can abut, or can be greater than zero, e.g., equal to or less than one of the following values: 2 mm, 1 mm, 0.9 mm, 0.8 mm, 0.7 mm, 0.6 mm, 0.5 mm, 0.4 mm, 0.3 mm. This distance can determine the amount of axial movement permitted in the cartridge assembly. For a non-zero distance, this distance can be maintained by a biasing member when the assembly is used in a drug delivery device.

[0063] In one embodiment, the cartridge assembly includes at least one coupling feature configured to couple to a housing capable of holding a drive mechanism, for example, a feature for a threaded or bayonet coupling.

[0064] In one embodiment, the cartridge assembly includes at least one interface or coding feature configured to cooperate with a corresponding interface or coding feature on the housing. The coupling feature and the interface or coding feature can be formed by the same feature or different features. The interface or coding feature can provide coding so that the cartridge assembly can only be assembled to a housing having a matching coding feature. This increases safety for the user and ensures that the contents of the cartridge in the cartridge assembly are aligned with a drive mechanism designed to dispense a specific drug or agent or a specific amount of drug or agent. If the cartridge assembly and drive mechanism do not match, the interface or coding features on the housing and cartridge assembly are not compatible, and the cartridge assembly cannot be coupled to the housing to form a drug delivery device.

[0065] As used herein, the terms "distal" and "proximal" can refer to opposite axial directions or axial ends. "Distal" can refer to a direction toward the dosing end or the end of a component of a cartridge, cartridge assembly, or drug delivery device that is located or to be located closest to the dosing end of the cartridge, cartridge assembly, or drug delivery device. "Proximal" can refer to a direction away from the dosing end or the end that is located or to be located farther away from the dosing end of the cartridge, cartridge assembly, or drug delivery device.

[0066] As used herein, the terms "axial," "radial," "angular," or "azimuthal" may be used with respect to the primary longitudinal axis of a device, cartridge, or cartridge assembly, e.g., an axis extending through the proximal and distal ends of a cartridge assembly, cartridge, or drug delivery device.

[0067] The features disclosed above in conjunction with the cartridge assembly or drug delivery device should not be considered to refer exclusively to the described aspects or embodiments. Conversely, these features also apply to other embodiments or aspects. Features disclosed in conjunction with the assembly also apply to the device, and vice versa. Of course, features disclosed in specific embodiments, as described above or below, can also be applied in combination with each other and / or with other features of other embodiments.

[0068] Further features, advantages, and advantageous embodiments of the present disclosure will become apparent from the following description of exemplary embodiments taken in conjunction with the drawings. [Brief explanation of the drawings]

[0069] [Figure 1-1]

[0023] Figures 1A-1F show an embodiment of a cartridge assembly based on a schematic perspective view in Figure 1A and a schematic cross-sectional view of the assembly in Figure 1B, and different views of the cartridge holder without a cartridge in Figures 1C-1F. Figures 1A-1F and their description are disclosed in European Patent Application No. 18305975.7. [Figure 1-2] Continued from Figure 1-1. [Figure 1-3] Continued from Figure 1-2. [Figure 2-1] 2A-2D are schematic cross-sectional views of a cartridge assembly to illustrate the technical problem on which the present invention is based and the various load paths that may occur in the cartridge holder. [Figure 2-2] Continued from Figure 2-1. [Figure 3] 3A and 3B are a schematic 3D view and a schematic cross-sectional view of a portion of a cartridge assembly having a flexible arm. [Figure 4] 4A-4C are a schematic 3D view and a schematic cross-sectional view of a portion of a distal member of a cartridge assembly according to a first embodiment of the present invention. [Figure 5] 5A and 5B are a schematic cross-sectional view and a schematic 3D view of a distal member of a cartridge assembly according to a second embodiment of the present invention. [Figure 6] 6A to 6C are schematic diagrams of a distal member of a cartridge assembly according to the first or second embodiment of the present invention. [Figure 7] 7A and 7B are schematic diagrams of preferred embodiments of the interface of the locking feature. [Figure 8] 8A and 8B are schematic 3D views of the distal region and fixation features. [Figure 9] 9A-9C are schematic cross-sectional views of embodiments that maintain the integrity of the seal. [Figure 10] 1 is a schematic diagram of one embodiment of a preferred shape of the locking feature. [Figure 11] 11A and 11B are schematic diagrams of a cartridge holder including a distal member of a cartridge and a member having increased stiffness. [Figure 12] 10A-10C show an embodiment of a drug delivery device having a cap covering the distal end of the device prior to a dose setting operation. [Figure 13] FIG. 6 shows the device of FIG. 5 with the cap removed to reveal the distal end of the cartridge assembly. DETAILED DESCRIPTION OF THE INVENTION

[0070] Throughout the figures, identical elements, elements of the same type, and elements that perform the same function may be provided with the same reference numerals.

[0071] In conjunction with these drawings, several embodiments of cartridge assemblies having locking features integrated into the cartridge holder of the assembly are disclosed below. Before disclosing the details of each embodiment, features applicable to all embodiments are discussed. Figures 1A-1F each show one embodiment of a cartridge assembly 300.

[0072] The cartridge assembly 300 includes a cartridge 301 and a cartridge holder 302. The cartridge 301 is disposed within a cartridge receiving or retaining section 303 of the cartridge holder. The cartridge retaining section is conveniently bounded, preferably circumferentially, by an inner wall 304 of the cartridge holder 302. The cartridge holder 302 has an opening 305. The opening 305 is conveniently a proximal opening. The proximal opening may provide access to the interior of the cartridge holder from the proximal end of the holder. The opening 305 allows the cartridge 301 to be inserted into the cartridge holder. The opening 305 allows the dosing end 306 of the cartridge to be inserted or introduced into the cartridge holder. The opposite end of the cartridge holder may be the distal end of the cartridge holder 302 and the end located closest to the dosing end 306 of the cartridge 301. The distal end of the cartridge holder is preferably designed to hold the cartridge in the holder, for example by abutment, so that the cartridge can only leave the cartridge holder through opening 305. The axial extension of the cartridge holder is expediently selected to cover at least 50%, preferably more than 60%, or more than 70%, for example more than 80% or more than 90% of the total length of the cartridge. As shown in the embodiment, the cartridge holder 302 can cover the entire cartridge.

[0073] The end of the cartridge opposite the dispensing end 306, i.e., the proximal end, is not explicitly shown in these figures. This end can be closed by a movable bung or stopper, also not explicitly shown. The bung or stopper can seal and close the proximal opening of the cartridge. A drug 307 or medication is contained within the region of the cartridge disposed between the dispensing end and the bung. Fluid communication is provided between the interior and exterior of the cartridge, allowing the drug to be dispensed from the cartridge through the dispensing end 306 when the bung is moved toward the dispensing end. The amount of drug 307 in the cartridge is preferably sufficient for multiple doses, and the dose size can be set by the user or fixed, for example, by the design of a drive mechanism used to deliver the drug from a drug delivery device including the cartridge.

[0074] At the dispensing end 306, the interior of the cartridge, which holds the drug or medication 307, is sealed by a septum 308. The septum 308 can be held by or fixed to the cartridge body 340 of the cartridge by a septum retainer 309. The septum 308 can be conveniently pierceable, for example, via a needle, to provide fluid communication between the interior and exterior of the cartridge. The septum retainer 309 can be formed by a cap, for example, a metal cap such as an aluminum cap. The metal cap can be connected to the cartridge body 340 via clamping or crimping. The cartridge body can be formed from glass. The body 340 can define the outer contour of the cartridge. In the area of ​​the dispensing end 306 where a needle should pierce the septum, an opening is provided in the septum retainer 309 to allow the needle to pass through the area of ​​the septum retainer. The cartridge 301 includes a head portion 310 and a main body portion 311. The head portion 310 is disposed toward the dispensing end 306. The main body portion 311 can be disposed closer to the proximal end of the cartridge than the head portion 310. A neck portion 312 can be disposed between the head portion 310 and the main body portion 311. The main body portion 311 can be a region through which a bung or stopper can move. The main body portion has a tubular configuration. The neck portion 312 can have a reduced diameter, outer diameter, and / or inner diameter compared to the main body portion 311. The head portion 310 has a reduced diameter, outer diameter, and / or inner diameter compared to the main body portion 311. The neck portion 312 has a reduced diameter compared to the main body portion and relative to the head portion 310. This diameter can be the extension of the cartridge 301 in a direction perpendicular to a major longitudinal axis of the cartridge or cartridge assembly extending between the proximal and distal ends. The neck portion may extend circumferentially. The entire cartridge 301 may be rotationally symmetrical about the main longitudinal axis.The transition between the head portion 310 and the neck portion 312 can be formed via a relatively steep surface, which preferably is less radially inclined than the surface provided between the neck portion 312 and the main body portion 311. Accordingly, the transition between the neck portion 312 and the main body portion 311 is less steep than the transition between the head portion 310 and the neck portion 312. Specifically, the cartridge surface 313, which can define the proximal boundary of the head portion 310, can have a lesser radial slope than the slope of the shoulder surface 314, which defines the distal boundary of the main body portion. The cartridge surface can be formed by the septum retainer 309 or, alternatively, by the cartridge body 340. The septum retainer 309 can secure the septum to the cartridge body. Thus, the septum retainer can extend from the distal end along the cartridge to a surface of the neck portion of the cartridge body facing away from the distal end of the cartridge, extending radially to secure the septum 308 to the cartridge body. The cartridge can include or consist of a cartridge body 340, a septum 308, a septum retainer 309, a drug or agent 307, and / or a bung (not explicitly shown).

[0075] The cartridge holder 302 includes a distal end wall 315 located opposite the opening 305 and / or on the end closest to the dispensing end 306 of the cartridge, i.e., its distal end. The distal end wall may extend circumferentially in a ring shape. A proximal surface of the distal end wall 315 is positioned to abut the distal end surface of the cartridge 301. In this manner, the cartridge 301 can be held within the cartridge holder, preventing distal movement of the cartridge 301 relative to the cartridge holder 302. The distal end wall 315 may define an opening 316 in the cartridge holder. The end wall may extend around the opening such that the opening is a central opening in the end wall. The opening may extend axially through the end wall 315. The opening 316 may be provided to allow a needle to be guided through the opening into the cartridge, particularly toward the septum 308.

[0076] The cartridge holder 302 can include a distal region 317 and a main body region 318. The distal region 317 is positioned closest to the dosing end of the cartridge and / or the distal end wall 315 of the cartridge holder. The main body region 318 is positioned farther from the distal end or distal end wall 315 and / or closer to the opening 305 than the distal region. Compared to the main body region, the distal region can have a reduced outer diameter. The reduction can be determined by a reduced diameter of the head portion compared to the diameter of the main body portion of the cartridge. The main body region 318 and the distal region can be connected by an inward shoulder region 331. A needle connector 319, e.g., a screw thread, can be disposed within the distal region. A needle unit, e.g., a hub of the needle unit, can be secured to the cartridge holder 302 via the needle connector. A needle held within the needle hub can be guided through the opening 316 to pierce the septum 308, providing fluid communication to the interior of the cartridge for dispensing the drug 307 or medicament from the cartridge 301. The distal region 317 can be designed to receive the head portion 310 of the cartridge 301 therein. The main body region 318 can be designed to receive the main body portion 311 of the cartridge. Toward the proximal end, the cartridge holder can have a coupling or interface region 320. Coupling or interface features can be provided within that region that are configured to cooperate with corresponding features on the housing 10 to couple the cartridge assembly 300 to the housing and form the drug delivery device 1 (see FIGS. 12 and 13 ). These coupling features can be designed for a threaded or bayonet connection between the cartridge holder and the housing. Preferably, the coupling or interface features are coded to the housing, which accommodates a drive mechanism designed for the drug or medicament contained within the cartridge of the cartridge assembly. This coding ensures that only the correct cartridge assembly can be assembled into the housing to form the drug delivery device.In this manner, it can be ensured that the medication in the cartridge assembly is dispensed using a drive mechanism specifically designed to dispense the contents of the cartridge. The drive mechanism can include a piston rod arranged to drive the bung or stopper distally relative to the cartridge, thereby dispensing the medication or medicament from the cartridge.

[0077] A radially outwardly projecting step 321 or flange may be provided between the proximal and distal ends of the cartridge holder 302, preferably closer to the proximal end than the distal end. The step or flange 321 may extend around the entire circumference of the cartridge holder 302. The proximal surface of the step 321 may be positioned to contact the distal surface of the housing when the cartridge assembly is coupled to the housing. The coupling region 320 may be covered by the housing when the assembly is coupled to the housing. However, the main body region 318 and the distal region 317 may protrude from the housing.

[0078] Furthermore, the cartridge holder 302 includes at least one locking feature 322. When viewed along the axial direction, the locking feature 322 is provided between two interior regions of the cartridge holder, one interior region adapted to receive and hold the head portion 310 and the other interior region adapted to receive and hold the main body portion 311 of the cartridge. The locking feature 322 can extend into the region of the neck portion of the cartridge 301. The locking feature 322 protrudes radially from the inner wall of the cartridge holder 302. Preferably, the locking feature 322 reduces the inner diameter of the cartridge holder, such that in that region the inner diameter is smaller than the outer diameter of the head portion of the cartridge.

[0079] Therefore, when the head portion of the cartridge is to be guided axially from the proximal opening past the locking feature, the locking feature must be deflected radially outward, e.g., only radially displaced. When the locking feature is deflected, the head portion can pass through the locking feature. Preferably, the locking feature is deflected by the head portion cooperating with a proximal surface of the locking feature, which can be oblique to the main axis of the cartridge holder, i.e., neither perpendicular nor parallel. After the head portion passes through the locking feature, the locking feature can again move radially inward, e.g., elastically. The internal region of the cartridge holder designed to receive the head portion 310 can have a reduced diameter compared to the region receiving the main body portion 311.

[0080] The locking feature 322 is integrally formed, for example by injection molding, with the outer surface or at least the portion of the cartridge holder that defines the outer contour of the cartridge holder. That is, if applicable, the outer surface of the cartridge holder can be provided with a coating, and the outer contour can still be defined by the portion of the cartridge holder with which the locking feature is integrated. An injection gate 323 is shown in Figures 1A-4A, indicating the location where the fluid plastic compound is injected into the mold cavity that defines the shape of the cartridge holder. The injection gate 323 can be located in the region of the distal end wall 315 of the cartridge holder, in particular on the distal face of the distal end wall.

[0081] The locking feature 322 includes a locking surface 324. The locking surface 324 may be a distal surface of the locking feature. Preferably, the locking surface is radially oriented, i.e., extends radially, and / or is planar. The locking surface 324 is positioned to abut or abuts a proximal, facing surface of the cartridge, such as the cartridge surface 313. The cartridge surface 313 and the locking surface 324 are thus positioned to prevent proximal removal of the cartridge from the cartridge holder through the opening 305 by mechanical cooperation with each other. Accordingly, the locking feature 322 prevents the cartridge from being removed from the holder through the opening 305. The locking feature 322 may be formed as a snap and / or clip feature. The angular extension of the fixation features or surfaces can be less than or equal to one of 20°, 15°, 10°, or in alternative embodiments, greater than or equal to 20°, such as 30°, 35°, 40°, 45°, 50°, 55°, or 60°. For example, the angular extension can be between 10° and 60°.

[0082] Furthermore, the outer wall of the cartridge holder is provided at the axial position of the locking feature. Therefore, the cartridge holder is closed at least in the area of ​​the locking feature. Accordingly, the locking surface and / or the locking feature cannot be accessed from the outside. This reduces the possibility of tampering with the cartridge assembly.

[0083] An embodiment of a cartridge holder having a locking feature integrated into the cartridge holder will now be discussed in more detail. The embodiment shown in Figures 1A and 1B has one, and in particular only one, locking feature 322. Of course, multiple locking features can be provided as well.

[0084] The locking feature 322 protrudes radially from the inner wall 304 of the cartridge holder 302. The locking feature 322 is disposed within the distal region 317 of the cartridge holder 302, particularly within the interior region of the cartridge holder on which the needle connector 319 is externally disposed. As is apparent from FIGS. 1A and 1B , the distal end wall 315, which has a generally ring-shaped configuration, has an opening 325. The opening 325 is oriented radially and interrupts the ring defined by the distal end wall 315. The opening 325 extends radially outward from the opening 316. The angular and radial position of the opening 325 can correspond to the locking feature 322 or the locking surface 324, and the opening is axially offset from the locking feature, e.g., in the distal direction. In particular, when viewed from the distal end along the axis, the locking surface is visible from the distal end. The locking surface can be radially and angularly surrounded by side walls that bound the opening 325. In these figures, the head portion 310 of the cartridge 301 is positioned between the opening 325 and the fixation surface 324. The angular and / or radial dimensions of the opening 325 can define, correspond to, or exceed the angular and / or radial dimensions of the fixation surface and / or fixation feature. Providing an opening in the distal end region facilitates molding of a cartridge holder with an integrated fixation feature with only minor modifications to the mold or tooling, compared to a cartridge holder without a fixation feature. In a cartridge holder without a fixation feature, the cartridge holder can be injection molded using two core pins of different diameters, one defining the interior of the distal region and the other defining the interior of the main body region 318 of the cartridge holder. The shorter core pin can define the interior in the distal region, and the longer core pin can define the interior in the main body region. The locking feature 322 can be integrated just at the intersection or boundary of two different core pins of an injection molding tool. The opening 325 can be formed during the molding process, and the opening 325 facilitates molding of the cartridge holder with the integrated locking feature 322.The opening 325 may be defined by, for example, a metal protrusion on the short core pin.

[0085] In the region where the locking feature 322 is provided, e.g., the distal region 317, the cartridge holder 302 can be radially deformable. Therefore, when the cartridge holder 302 is exposed to an axial or radially outward force, its inner diameter can increase. The ability of the cartridge holder 302 to radially deform when exposed to a radial force can be increased in an angular portion of the distal region 317 that angularly overlaps the opening 325. The locking feature 322 is located in this region because it angularly overlaps the opening. The locking feature is conveniently inflexible and / or rigid, e.g., having a greater rigidity than the inner wall of the distal region 317 or the first region where the head portion of the cartridge is to be disposed. Therefore, for example, when an axial and / or radial force acts on the locking feature 322 while the head portion is being guided along the locking feature 322 and in contact with the locking feature 322, the cartridge holder 302 is expanded due to the rigidity of the locking feature 322. The locking feature 322 itself does not deform or bend, or at least not significantly so, compared to the deformed portions of the cartridge holder, e.g., the distal region 317 or the shoulder region 331. Conveniently, since the cartridge holder 302 is plastic, deformation of the locking feature itself to a very limited extent cannot be avoided. However, in the proposed concept, the cartridge holder is expanded within a circumferentially closed region of the cartridge holder 302, facilitating insertion of the cartridge into the cartridge holder. When the cartridge is introduced into the cartridge holder, the cartridge holder is deformed. The deforming region is conveniently an area that does not have flexible arms, tongues, or tab-like features. The locking feature 322 is used to transmit the insertion force of the cartridge to the cartridge holder and expand the cartridge holder laterally. The interior of the cartridge holder is expanded within the mechanical contact region between the cartridge and the cartridge holder, i.e., within the region where the locking feature is located, preferably within an axially and / or circumferentially adjacent region.Widening the interior of the cartridge holder, as opposed to a separate flexible arm, tongue, or tab-like feature that deflects, can provide a more stable fixation of the cartridge within the cartridge holder after the cartridge is introduced into the cartridge holder. After head portion 310 passes locking feature 322, the locking feature is again displaced inward, e.g., by elastic deformation, so that cartridge face 313 and locking face 324 are positioned as shown in FIG. 1B. The locking feature preferably does not deform, or at least not significantly deform, in particular does not axially deflect or pivot, during this process.

[0086] As shown in FIG. 1B , a ramped surface 326 is positioned distally from the fixing surface 324, and the ramped surface 326 rises distally along its radial extension. This surface is preferably positioned opposite the fixing surface, or at least angularly offset from the fixing surface, and allows radial movement of the head portion 310 of the cartridge 301 to a region where it radially overlaps the fixing surface 324. The ramped surface thus acts as a cartridge guiding feature during the assembly process of the cartridge assembly 300. Therefore, references to the ramped surface 326 can be considered to be references to the cartridge guiding feature, and vice versa. In this way, the radial overlap between the fixing surface 324 and the surface 313 of the cartridge 301 can be increased when the cartridge reaches its final position. The ramped surface 326 can enhance the stability of the locking of the cartridge into the cartridge holder, for example, when only one fixing feature is provided.

[0087] The distal offset of the cartridge guiding feature 326 from the radially free end of the locking feature, locking surface 324, and / or locking feature 322 (highlighted by "B" in FIG. 1B ) can be greater than the thickness of the cartridge septum 308 (highlighted by "A" in FIG. 1B ). This ensures that when the cartridge interacts with the locking feature 322, displacing it radially outward and temporarily widening the interior of the cartridge holder, the septum retainer 309 is reinforced, preferably by the more rigid cartridge body 340 rather than the septum. Thus, the force required to displace the feature 322 is not transmitted to the septum. If this force were transmitted to the septum, there would be a significantly increased risk of deformation of the septum retainer 309, which may be a thin metal component, or damage to the septum. A distal offset between the cartridge guiding feature 326 and locking surface 324 greater than the thickness of the septum 308 avoids this. Distal offset B is expediently less than the axial extension of cartridge head portion 310. In this manner, the cartridge guiding features, by cooperating with head portion 310, can adequately guide cartridge 301 radially inward.

[0088] Within the region of the cartridge holder 302 between the cartridge guiding feature 326 and the fixation surface 324, if such a region exists, the inner diameter of the cartridge holder interior can be larger than within the region of the cartridge guiding feature and / or within a region distal to the cartridge guiding feature. Such a region may or may not exist. Within the region of the cartridge holder between the cartridge guiding feature and the fixation surface, the inner diameter can be larger than within the fixation feature region. Within the region of the cartridge guiding feature 326 and / or within a region distal to the cartridge guiding feature, the inner diameter of the cartridge holder can be larger than within the fixation feature region, e.g., equal to or greater than the outer diameter of the head portion 310.

[0089] In other words, the septum retainer or metal sleeve 309 has a distal section that surrounds the soft septum 308 and a proximal section that surrounds the neck of the cartridge body or glass ampoule 340. After the distal section of the septum retainer moves past the fixation surface 324, it advantageously contacts the cartridge guide feature or ramped surface 326. In this way, radial overlap between the metal sleeve 309 and the fixation surface is minimized during assembly, which could cause the fixation surface to damage the metal sleeve 309; this overlap only increases as the fixation surface moves past the distal section of the metal sleeve 309 and applies radial pressure to the proximal section. The proximal section is not damaged or dented because it is supported by a harder, e.g., glass-like, material than the distal section. The final overlap between the fixation surface and the cartridge surface at the end of the assembly process remains large. The final overlap may be defined by a smaller inner diameter of the cartridge holder in the area of ​​the ramped surface that marks the end of ramped surface 326 .

[0090] When a cartridge holder 302 with an integrated locking feature 322 was tested, it was discovered that unless the diameter before the inclined surface 326 was sufficiently larger than the diameter after the inclination 326, the distal section of the septum retainer 309 would be significantly recessed, thus causing minimal, if any, interference of the distal section of the septum retainer, which could cause the cartridge 301 to move away from the locking feature, and this interference only increased after the locking feature pressed against an area of ​​the septum retainer 309, for example, the head portion of the glass cartridge body, which reinforces / supports the septum retainer, which is a thin, easily deformable metal component.

[0091] After the cartridge 301 is assembled to the cartridge holder 302, the locking feature 322 can prevent proximal movement of the cartridge 301 relative to the holder 302. However, the locking feature conveniently only prevents removal of the cartridge from the cartridge holder, rather than periodically applying a clamping force, e.g., a distal or radial force, to the cartridge. In this way, the force load on the cartridge can be advantageously low.

[0092] 1C-1F show additional views of the cartridge holder 302. FIG. 1C shows a view from the distal end. As will be readily apparent, the angular dimension of the locking feature 322 is smaller than the angular dimension of the opening 325. The radial dimension of the locking feature 322 or locking surface is likewise smaller than the radial dimension of the opening 325. From FIG. 1D, which also shows the distal end but in a perspective view, it can be inferred that the cartridge holder, particularly the distal region 317, is reinforced, i.e., has a higher wall strength or thickness, in the region angularly adjacent to the locking feature 322. A reinforcement section 341 extends circumferentially within the cartridge holder. The reinforcement section may axially overlap the locking feature. Alternatively or additionally, the reinforcement section 341 may be positioned distally offset from the locking feature 322. In the area of ​​the interior of the cartridge holder that angularly overlaps the locking feature, the reinforcing section is preferably interrupted to promote radial deformability of the cartridge holder when the head portion radially displaces the locking feature 322.

[0093] When viewed axially from the opening 325 toward the fixation surface 324, the wall thickness of the holder 302 can be smaller than the wall thickness within the reinforcing section 341. The wall thickness of the cartridge holder 302 defined by the fixation features in the region of the fixation features 322 can be larger than the wall thickness within the reinforcing section 341. The fixation features 322 can protrude radially above the reinforcing section 341. The reinforcing section 341 is also shown in FIG. 1F , which shows a perspective cross-sectional view of the cartridge holder 302. In FIG. 1F , as well as in FIG. 1E , which shows a view from the proximal end of the cartridge holder 302, the interior of the cartridge holder is shown to include a plurality of circumferentially arranged, preferably equally spaced, spacer features or cartridge support features 342, e.g., ribs. The features 342 are axially oriented. The features 342 can be provided to radially support the cartridge, e.g., its main body portion 311, when the cartridge is held within the cartridge holder. These features may be the only difference between a cartridge holder that receives a cartridge having a smaller diameter and a cartridge that receives a cartridge having a larger diameter. Cartridge holders for larger diameter cartridges conveniently do not have cartridge support features 342. Thus, while the external dimensions of the cartridge holders are the same, the outer diameters of the cartridges held within the cartridge holders are different.

[0094] As is apparent from these figures, e.g., FIG. 1B , the needle connector 319, e.g., threads, is distally offset from the locking feature 322. Specifically, the region between the locking feature and the cartridge guide feature or ramped surface 326 does not include the needle connector 319. The needle connector can axially overlap the cartridge guide feature 326 or can be distally offset from this feature 326. Thus, the axial extension of the needle connector 319 can be smaller than in other cartridge holder designs. For example, the needle connector 319 can be limited to a distal section of the cartridge holder distal region 317, with a connector-free region disposed between the needle connector 319 and the main body region. The axial extension of the connector-free region can be greater than 50% of the axial extension of the distal section having the needle connector. The axial extension of the distal section having the needle connector can be greater than the axial extension of the connector-free region. For example, to maintain a given outer profile or dimension of cartridge holder 302, the cartridge holder in the region between locking feature 322 and guiding feature 326 has a reduced wall thickness, increasing the inner diameter of cartridge holder 302, so providing the additional radial recess required for connector 319 outside of this region would increase the risk of damaging or even rendering the cartridge holder unmoldable in this region. Therefore, a shortened needle connector is advantageous.

[0095] The illustrated embodiment shows only one locking feature, but if multiple locking features are used, a ramp surface may also be provided, although in the following embodiments ramp surfaces are not shown.

[0096] 2A-2D show cross-sectional views of cartridge 301 and cartridge holder 302 and various load paths that may occur within cartridge holder 302 as cartridge 301 is moved distally or proximally.

[0097] As described above, in the region where the locking feature 322 is provided, for example, in the distal region 317, the cartridge holder 302 can be radially deformable. Therefore, when the cartridge holder 302 is exposed to a radially outward force, its inner diameter can increase. When an axial and / or radial force acts on the locking feature 322, for example, while the head portion is guided along the locking feature 322 and in contact with the locking feature 322, the cartridge holder 302 is expanded due to the rigidity of the locking feature 322. After the head portion 310 passes the locking feature 322, the locking feature is displaced inward again, for example, due to elastic deformation, and the cartridge face 313 and the locking face 324 are positioned as shown in FIG. 1B .

[0098] Disassembly of the cartridge 301 due to tampering or impact is likely to involve proximal movement of the cartridge 301 relative to the cartridge holder 302. In this situation, the proximally facing surface of the septum retainer 309 contacts the locking feature 322 and applies a generally proximal load to the cartridge 301. This load causes deformation of the cartridge holder 302. The locking feature 322 is likely to bend in the proximal direction.

[0099] However, the fixation features 322 can also bend radially inward or outward in the direction of a Y-axis oriented generally perpendicular to the distal and proximal directions. See dashed arrows in Figure 2A. The bending of the fixation features 322 does not necessarily follow the exact direction of the Y-axis shown, but rather is generally inward or outward relative to the longitudinal axis of the device.

[0100] This radial deflection in the Y-axis affects the retention strength. In situations where there is radial outward bending along the Y-axis as the load increases, the radial engagement of the locking feature 322 with the septum retainer 309 decreases. If the load is large enough, the engagement decreases to the point where the septum retainer 309 slips past the locking feature 322 and / or the locking feature 322 plastically deforms, allowing the cartridge 301 to disassemble. Additionally, the septum retainer 309 is likely to have a fillet on its outer edge, which will at some point contact the locking feature 322 as the engagement decreases, accelerating the disassembly process. This likely results in a lower retention strength. In situations where there is radial inward bending as the load increases, the radial engagement of the locking feature 322 with the septum retainer 309 increases. Therefore, the behavior is “self-locking,” which tends to provide a higher retention force. Additionally, the fixation strength is likely to be less affected by the size of the initial engagement and therefore less likely to vary with tolerances of the cartridge 301 or cartridge holder 302.

[0101] The radial inward or outward deflection of the locking features 322 in the direction of the Y-axis depends on the load path followed by the load applied to the locking features 322 by the cartridge septum retainer 309. By way of example, three possible load paths within the cartridge holder 302 are shown in FIG. 2B: distal load path DLP, circumferential load path CLP, and proximal load path PLP. The amount of load extending along each load path DLP, CLP, PLP depends on the stiffness of the corresponding load path DLP, CLP, PLP, with stiffer load paths absorbing larger loads than less stiff load paths.

[0102] When cartridge 301 is inserted distally into opening 325 of cartridge holder 302 , at some point the distal-most face of cartridge 301 passes through locking feature 322 .

[0103] The cartridge 301 can be inserted into the cartridge holder through the opening 305. The dosing end 306 of the cartridge can be inserted or introduced into the cartridge through the opening 305. The opposite end of the cartridge holder is the distal end of the cartridge holder 302, which can be the end located closest to the dosing end 306 of the cartridge 301. The distal end of the cartridge holder is preferably designed to hold the cartridge in the holder, for example by abutment, so that the cartridge can only leave the cartridge holder through the opening 305.

[0104] When the cartridge 301 is fully inserted into the cartridge holder, such that the distal end of the cartridge holder 302 is located closest to the dispensing end 306 of the cartridge, the distal end of the locking feature 322 retains the cartridge 301 within the holder. During insertion, the cartridge 301 passes through the locking feature 322, applying a distal load to the locking feature 322. This causes the distal load path DLP and the circumferential load path CLP to also act on the distal region 317. When the cartridge 301 is moved proximally from the retained position, the cartridge 301 applies a load to the locking feature through the septum retainer 309, which connects to the proximal load path PLP. The septum retainer 309 then acts proximally toward the locking feature 322, which connects to the load and the proximal load path PLP, as shown in FIG. 2B .

[0105] Each load path DLP, CLP, PLP tends to produce a different deflection mode. The two main load paths DLP, PLP with very different deflection modes are shown separately in Figures 2C and 2D.

[0106] As shown in FIG. 2C, the distal load path DLP tends to result in radially outward bending of the fixation features 322, as indicated by the dashed arrows.

[0107] As shown in FIG. 2D, the proximal load path PLP tends to result in radial inward bending of the fixation feature, as indicated by the dashed arrow.

[0108] The distal load paths DLP, CLP tend to cause radially outward deflection, and the proximal load path PLP tends to cause radially inward deflection.

[0109] 3A and 3B show a schematic 3D view and a cross-sectional view of a cartridge holder with a cartridge and a flexible arm as known from the prior art.

[0110] A self-locking behavior can be achieved using a flexible arm 345 extending into the distal region 317 of the cartridge holder 302. The flexible arm 345 extends proximally into the shoulder region 331. The flexible arm 345 is secured at the shoulder region 331 and is flexible in the radially inward and outward directions. The flexible arm 345 is surrounded by a U-shaped opening 347. However, this concept has several disadvantages. First, its function as a cartridge securing feature is obvious to an observer looking at the outer surface of the member. Second, it is accessible for manipulation with a thin, bladed tool such as a screwdriver. Third, the inherent flexibility of the flexible arm 345 limits its radial stiffness. This makes it easier to manipulate the flexible arm 345 and prevents it from effectively retaining the cartridge 301.

[0111] 4A to 4C show a schematic 3D view and a cross-sectional view of the distal member of the cartridge holder of the first embodiment of the present invention.

[0112] 4A shows a schematic cross-sectional view of the distal region 317 and a portion of the main body region 318 of the cartridge holder 302, as well as the cartridge 301 disposed within the cartridge holder 302. A shoulder region 331 is disposed between the distal region 317 and the main body region 318 of the cartridge holder 302.

[0113] Located adjacent to this shoulder region 331 is a region 350 having reduced mechanical stiffness, which is positionally fixed and includes an aperture. The purpose of the region 350 having reduced mechanical stiffness is to reduce or eliminate loads generated from the cartridge 301 through the distal load paths DLP, CLP toward the fixation feature 322 during proximal movement of the cartridge 301, and thus its tendency to flex radially outward. This therefore increases the amount of load that travels through the proximal load path PLP with a radially inward deflection. In this embodiment, the region 350 having reduced mechanical stiffness includes an aperture. The addition of an aperture provides self-locking behavior and significantly increases fixation strength.

[0114] Additionally, by reducing or eliminating the distal load paths DLP, CLP, the stiffness of the cartridge holder 302 in response to proximal loads from the cartridge 301 is reduced. This means that during an impact loading scenario, the force generated is also reduced because the impact energy can be absorbed over a longer deflection distance. This also tends to increase fixation strength.

[0115] The aperture can extend radially through the side wall of the cartridge holder, particularly through the entire side wall from the exterior of the cartridge holder to the interior of the cartridge holder. The aperture can be located in a distal region of the cartridge holder and / or can be limited to the distal region of the cartridge holder. The aperture can extend circumferentially and / or be oriented circumferentially, for example as a slit. The aperture can be located parallel to the coupling feature, which can be a thread. The aperture in the side wall of the cartridge holder can be defined by a molding tool and can abut radially against the outer surface of a core pin of the molding tool during production, with the core pin defining the interior of the cartridge holder in the region where the aperture is located, for example in the distal region. In this way, the fixation feature can be defined without changing the core pin relative to the interior of the cartridge holder.

[0116] Thus, the present invention is an improvement over what is known in the art regarding tamper protection for preventing unauthorized disassembly of cartridge 301, as the locking features are less visually apparent and less accessible for manipulation by tools.

[0117] Figure 4B shows a schematic 3D view of the distal region 317, shoulder region 331, and a small portion of the main body region 318 of the cartridge holder 302. Figure 4B also shows a region 350 having reduced stiffness distally adjacent the shoulder region 331.

[0118] FIG. 4C shows a schematic 3D view of a longitudinal cross section of cartridge holder 302.

[0119] FIG. 5A shows a schematic cross-sectional view of the distal region 317, a portion of the main body region 318 of the cartridge holder 302, as well as a portion of each of the cartridges 301 disposed within the cartridge holder 302.

[0120] The amount of load that travels along each load path DLP1, DLP2, PLP depends on the stiffness of the load path. Higher stiffness load paths absorb more load than lower stiffness load paths. Adjusting the amount of stiffness can be achieved by varying the size and depth of apertures located similarly to the apertures in the previous embodiment. This area of ​​reduced stiffness can take many forms, in addition to or instead of apertures, and can involve profiling of both the interior and exterior surfaces. A simple example of using reduced wall thickness is in the form of a groove.

[0121] An added benefit of this design is that the lack of apertures makes external manipulation of the locking feature much more difficult, further increasing the tamper resistance of the locking method.

[0122] 5B shows a schematic 3D view of the distal region 317, shoulder region 331, and a portion of the main body region 318 of the cartridge holder 302. In the distal region 317, a region of reduced stiffness 350 is shown in the form of a rectangular groove. The groove is located adjacent to the shoulder region 331. The long sides of the rectangle extend parallel to the shoulder region.

[0123] 6A-6C show schematic cross-sectional views of the distal region 317 of the cartridge holder 302 of the first or second embodiment of the present invention. These show some examples of possible shapes of the aperture, which can be rectangular and may or may not have rounded edges. These examples are not exclusive; other shapes, such as circular or triangular shapes, may also exist that create a region with reduced stiffness that leads to the desired load path.

[0124] 7A-7B show schematic diagrams of preferred embodiments of the interface of the fixation feature.

[0125] This concept also includes several additional features that serve to increase the self-locking behavior.

[0126] The locking surface 324 of the locking feature 322 can be a convex curve, so that the center of the locking surface 324 preferentially contacts the cartridge septum retainer 309. This is shown in the schematic cross-section of Figure 7A. This can provide increased self-locking behavior.

[0127] Alternatively, as shown in the cross-sectional view of a portion of the locking feature 322 and septum retainer 309 in Figure 7B, the locking surface 324 can be angled to preferentially contact the cartridge septum retainer 309 at the radially inner edge of the locking feature 322. This can provide increased self-locking behavior. Additionally, the geometry of the septum retainer 309 tends to be more uniform at smaller radii, providing improved consistency of behavior.

[0128] 8A and 8B show a schematic 3D view of distal region 317 and fixation feature 322 with a pocket of material removed in the region radially outward of fixation feature 322. FIG.

[0129] This can provide increased self-locking behavior. An additional benefit of the aperture is that the force required to assemble the cartridge into the cartridge holder 302 is reduced due to the increased flexibility of the locking function provided by the aperture.

[0130] 9A-9C show schematic cross-sectional views of an embodiment that maintains the integrity of the seal.

[0131] In the 1.5 mL and 3 mL cartridges 301, the septum retainer 309 is supported along part of its length by the septum 308 and along part of its length by the cartridge glass. Because the septum 308 is more flexible and is also the component that provides the sealing interface, high radial contact pressures applied to areas supported only by the septum 308 are more likely to compromise the integrity of the seal than contact pressures applied to areas supported by the cartridge glass.

[0132] To address this risk, the cartridge holder needle hub bore includes a first inner diameter 328 and a second inner diameter 329, with a conical surface connecting them together. The first inner diameter 328 can be larger than the second inner diameter 329, and the second inner diameter 329 can be located distally from the first inner diameter 328.

[0133] This geometry is intended to reduce interference between the septum retainer 309 and the locking feature 322 while the locking feature 322 is in contact with the area of ​​the septum retainer 309 supported by the septum 308, thereby reducing the probability of compromising the integrity of the seal.

[0134] As septum retainer 309 gains support from the glass, it transitions to contact the conical surface, increasing the interference and allowing septum retainer 309 to withstand more deformation. Towards the end of the assembly process, in the final assembled state, septum retainer 309 contacts area 329, which has a smaller diameter, thus providing increased interference and therefore retention strength. This design therefore allows for greater assembly interference, which improves retention strength and likely minimizes the risk of compromising the integrity of the seal.

[0135] 9A illustrates assembly process step 1. During distal insertion of cartridge 301 into cartridge holder 302 through opening 305, at some point, the distal member of cartridge 301 contacts locking feature 322. Locking feature 322 deflects outward, and on the opposite side of locking feature 322 within cartridge holder 302, cartridge 301 slides along the interior sidewall of cartridge holder 302, contacting larger diameter surface 328, while the locking feature contacts the surface of the septum retainer supported by the septum, reducing interference and thus applying contact pressure to the weaker member of the septum retainer. Thus, on the opposite side of locking feature 322 within cartridge holder 302, cartridge 301 slides along the interior sidewall of cartridge holder 302.

[0136] 9B shows assembly process stage 2. As the cartridge is moved further distally, the inner diameter of cartridge holder 302 decreases, thus forcing cartridge 301 into press-fit contact with the inner wall of cartridge holder 302. As the locking features contact the surface of the septum retainer supported by the cartridge glass and interference increases, the contact transitions to surfaces of progressively smaller diameter.

[0137] 9C shows assembly process stage 3. As the cartridge is moved further distally, septum retainer 309 passes completely through locking feature 322. Locking feature 322 then deflects radially inward and abuts cartridge 301, preventing proximal movement of cartridge 301. The distal member of septum retainer 309 is surrounded from cartridge holder 302 by region 329, which has a smaller inner diameter.

[0138] FIG. 10 shows a schematic diagram of one embodiment of a preferred shape for the locking feature 322.

[0139] As an additional feature to reduce local peak contact pressures on the septum retainer and the risk to seal integrity, the fixation features also have a profile such that interference peaks at the center of the feature and decreases towards the edges.

[0140] 11A-11B show schematic cross-sectional and 3D views of a cutaway portion of the distal member of the cartridge holder. Alternatively, the goal is to further increase the tamper resistance of the retention method, since the absence of openings makes external manipulation of the retention feature even more difficult. This can be achieved by incorporating an area of ​​increased stiffness 355 in the proximal load path (rather than incorporating an area of ​​reduced stiffness in the distal load path). For example, the fixation feature 322 can be thickened or include an additional layer to locally increase stiffness.

[0141] 12 and 13 schematically illustrate an embodiment of a drug delivery device suitable for use with the disclosed cartridge assembly. FIG. 12 illustrates the device 1 with a cap 120 attached and covering the cartridge assembly 300. In FIG. 13, the cap has been removed. The cartridge assembly 300 is conveniently releasably coupled to a body or housing 10 of the drug delivery device 1, as shown in FIG. 13. The housing conveniently defines the outer contour of the device and may be sleeve-shaped. A needle connector 319 may be coupled to a needle unit for dispensing a drug or medication from the device 1. A dose setting member 70 is movably held within the housing 10 and may be manipulated by a user to set a dose. For example, the dose setting member 70 may be rotated relative to the housing to set a dose. The device may be a variable dose device, where the size of the dose is variable by the user rather than being predetermined by the design of a drive mechanism held within the housing. FIG. 13 shows the dose setting state of the drug delivery device, where the numerical value (not shown) displayed in the window 230 has been changed to indicate the size of the currently set dose compared to FIG. 12 . The device can be designed so that the dose setting member 70 is displaced proximally relative to the housing 10 during dose setting. Alternatively, the dose setting member can remain in the same axial position regardless of the set dose. From the position shown in FIG. 13 , the dosing operation can be initiated by distally moving or applying a distal force to the dose setting member 70 or dose dispensing member provided at the proximal end of the drug delivery device 1. To dispense a dose, the bung is displaced distally relative to the cartridge, for example, by the device's piston rod (not explicitly shown). A cartridge biasing member, such as a rubber spring washer or elastic cushion, can be arranged inside the housing (not explicitly shown). The biasing member can bias the cartridge distally into contact with the proximal face of the cartridge holder, for example, the inner surface of the distal end wall 315.The biasing member may directly abut the cartridge, eg, the cartridge body, eg, at its proximal end, to transfer its load to the cartridge, or may abut indirectly via a rigid spacer component.

[0142] The current design is intended for use when holding 1.5 mL and 3 mL cartridges within the cartridge holder. However, the current design can be easily adapted to hold any cartridge, ampoule, or container within the housing when the benefits of simple assembly, high retention strength, and improved tamper resistance are required.

[0143] The scope of protection is not limited to the examples set out herein above: every invention disclosed herein is embodied in each and every novel feature and combination of features, and in particular includes every combination of features claimed, even if that feature or combination of features is not explicitly stated in the claims or examples.

[0144] The terms "drug" or "medicament" are used interchangeably herein to describe a pharmaceutical formulation containing one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally a pharmaceutically acceptable carrier. An active pharmaceutical ingredient ("API"), in its broadest sense, is a chemical structure that has a biological effect on humans or animals. In pharmacology, drugs or medications are used to treat, cure, prevent, or diagnose disease or otherwise improve physical or mental well-being. Drugs or medications can be used for a limited duration or periodically for chronic disorders.

[0145] As described below, drugs or pharmaceutical agents may contain 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 having a molecular weight of 500 Da or less, polypeptides, peptides, and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes), carbohydrates and polysaccharides, 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 can be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also contemplated.

[0146] The drug or agent can be contained in a primary package or "drug container" adapted for use in a drug delivery device. The drug container can be, for example, a cartridge, syringe, reservoir, or other rigid or flexible vessel configured to provide a chamber suitable for storage (e.g., short-term or long-term storage) of one or more drugs. For example, in some cases, the chamber can be designed to store the drug for at least one day (e.g., from one day to at least 30 days). In some cases, the chamber can be designed to store the drug for about one month to about two years. Storage can occur at room temperature (e.g., about 20°C) or refrigerated temperatures (e.g., from about -4°C to about 4°C). In some cases, the drug container can be or include a dual-chamber cartridge configured to separately store two or more components of a pharmaceutical formulation to be administered (e.g., an API and a diluent, or two different drugs), one in each chamber. In such cases, the two chambers of the dual-chamber cartridge can be configured to allow mixing between two or more components prior to and / or during administration to the human or animal body. For example, the two chambers can be configured to be in fluid communication with each other (e.g., via a conduit between the two chambers) and to allow mixing of the two components by a user, if desired, prior to administration. Alternatively or additionally, the two chambers can be configured to allow mixing upon administration of the components to the human or animal body.

[0147] The drugs or agents contained in the drug delivery devices described herein can be used to treat and / or prevent many different types of medical disorders. Examples of disorders include, for example, diabetes or complications associated with diabetes, such as diabetic retinopathy, and thromboembolic disorders, such as deep vein thromboembolism or pulmonary embolism. Further examples of disorders include acute coronary syndrome (ACS), angina, 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 Rote Liste 2014 (e.g., but not limited to, Main Group 12 (antidiabetic agents) or 86 (oncology agents)) and the Merck Index, 15th edition.

[0148] Examples of APIs for the treatment and / or prevention of type 1 or type 2 diabetes or complications associated with type 1 or type 2 diabetes include insulin, e.g., human insulin, or a human insulin analog or derivative, glucagon-like peptide (GLP-1), a GLP-1 analog or GLP-1 receptor agonist, or an analog or derivative thereof, a dipeptidyl peptidase-4 (DPP4) inhibitor, or a pharmaceutically acceptable salt or solvate thereof, or any mixture 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 present in the naturally occurring peptide and / or by addition of at least one amino acid residue. refers toThe added and / or replaced amino acid residues can be either codable amino acid residues, other naturally occurring residues, or purely synthetic amino acid residues. Insulin analogs are also called "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, for example, the molecular structure of human insulin, with one or more organic substituents (e.g., fatty acids) attached to one or more of the amino acids. Optionally, one or more amino acids present in the naturally occurring peptide are deleted and / or replaced by other amino acids, including non-codable amino acids, or amino acids, including non-codable ones, are added to the naturally occurring peptide.

[0149] 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 at position B28 is replaced by Asp, Lys, Leu, Val or Ala and the Lys at position B29 may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0150] Examples of insulin derivatives are, for example, 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-myristoylLysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin. B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-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.

[0151] Examples of GLP-1, GLP-1 analogs and GLP-1 receptor agonists are, for example, lixisenatide (Lyxumia®), exenatide (exendin-4, Byetta®, Bydureon®, a 39 amino acid peptide produced by the salivary glands of the flathead monster), liraglutide (Victoza®), semaglutide, taspoglutide, albiglutide (Syncria®), dulaglutide (Trulicity®), rexendin -4, CJC-1134-PC, PB-1023, TTP-054, langrenatide / HM-11260C, CM-3, GLP-1 Erigen, ORMD-0901, NN-9924, NN-9926, NN-9927, nodexene, Viadol-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR709, ZP-2929, ZP-3022, TT-401, BHM-034, MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, exenatide-XTEN, and glucagon-Xten.

[0152] An example of an oligonucleotide is, for example, mipomersen sodium (Kynamro®), a cholesterol-lowering antisense therapeutic for the treatment of familial hypercholesterolemia.

[0153] Examples of DPP4 inhibitors are vidagliptin, sitagliptin, denagliptin, saxagliptin, and berberine.

[0154] Examples of hormones include pituitary or hypothalamic hormones or regulatory active peptides and their antagonists, such as gonadotropins (follitropin, lutropin, chorion gonadotropin, menotropin), somatropine (somatropin), desmopressin, terlipressin, gonadorelin, triptorelin, leuprorelin, buserelin, nafarelin, and goserelin.

[0155] Examples of polysaccharides include glycosaminoglycans, hyaluronic acid, heparin, low-molecular-weight heparin or ultra-low-molecular-weight heparin or derivatives thereof, or sulfated polysaccharides, such as the polysulfated forms of the aforementioned polysaccharides, and / or pharmaceutically acceptable salts thereof. An example of a pharmaceutically acceptable salt of polysulfated low-molecular-weight heparin is enoxaparin sodium. Examples of hyaluronic acid derivatives include Hylan G-F20 (Synvisc®) and sodium hyaluronate.

[0156] As used herein, the term "antibody" refers to an immunoglobulin molecule or an antigen-binding portion thereof. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments that retain antigen-binding ability. 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 function and is capable of fixing 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, antibody fragment, or mutant that does not support Fc receptor binding, e.g., has 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 (CODVs) with a crossover binding region orientation.

[0157] The term "fragment" or "antibody fragment" refers to a polypeptide (e.g., an antibody heavy and / or light chain polypeptide) derived from an antibody polypeptide molecule that does not include the full-length antibody polypeptide but comprises at least a portion of the full-length antibody polypeptide that is still capable of binding to antigen. Antibody fragments can 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, e.g., bispecific, trispecific, tetraspecific, and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent or multivalent antibody fragments, e.g., 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.

[0158] 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 orientation of the CDR sequences to enable antigen binding. Although the framework regions themselves typically do not directly participate in antigen binding, as is known in the art, certain residues within the framework regions of a particular antibody may be directly involved in antigen binding or may affect the ability of one or more amino acids within the CDRs to interact with the antigen.

[0159] 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).

[0160] Pharmaceutically acceptable salts of any of the APIs described herein are contemplated for use as drugs or medicaments in drug delivery devices. Pharmaceutically acceptable salts include, for example, acid addition salts and base salts.

[0161] Those skilled in the art will understand that modifications (additions and / or deletions) can be made to the various components of the APIs, configurations, 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 all equivalents thereof. [Explanation of symbols]

[0162] 300 Cartridge Assembly 301 Cartridge 302 Cartridge holder 303 Cartridge Retaining Section 304 Interior wall 305 Opening 306 Medication End 307 Drugs / Medications 308 Septum 309 Septum holder 310 Head part 311 Main body part 312 Neck part 313 Cartridge surface 314 Shoulder 315 Distal end wall 316 Opening 317 Distal Region 318 Main body area 319 Needle Connector 320 Consolidation Area 321 steps 322 fixed functions 323 Injection Gate 324 Fixed surface 325 Opening 326 Surface 327 Opening 328 region having a first inner diameter 329 Region with second inner diameter 331 Shoulder area 340 cartridge body 341 Reinforcement Section 342 Cartridge support function 1. Drug delivery devices 120 Cap 70 Dose setting member 10. Housing 230 Window A Thickness B distance PLP proximal load pathway DLP distal load pathway CLP Circumferential Load Path Y Axis perpendicular to the distal or proximal direction 345 Flexible Arm 347 U-shaped cavity 350 Region with reduced mechanical stiffness 355 Regions with increased mechanical stiffness

Claims

1. A cartridge assembly (300) for a drug delivery device comprising: a cartridge (301) containing a drug (307); a cartridge holder (302) defining an internal cartridge receiving section (303) in which the cartridge is placed; a cartridge holder (302), the cartridge holder (302) comprising a distal region (317) and a main body region (318), the distal end of said distal region (317) having a needle connector (319) disposed thereon; - a fixation feature (322) located in said distal region (317); - a region (350) having reduced mechanical stiffness compared to the stiffness of the main body region (318), wherein the region (350) having reduced mechanical stiffness is integrated into the distal region (317) and is positioned between the needle connector (319) and the locking feature (322), such that when the cartridge (301) is moved proximally, the loads generated are transmitted proximally from the cartridge (301) to the locking feature (322) and then to the main body region (318).

2. The cartridge assembly of claim 1 , wherein the region (350) having reduced mechanical stiffness comprises a groove or an aperture.

3. The cartridge assembly of claim 2 , wherein the groove or aperture comprises a rectangular or rounded rectangular shape.

4. the locking feature (322) comprises a locking surface (324), in particular a radially oriented surface, which is arranged to abut against a cartridge surface (313), in particular a radially oriented surface, of the cartridge to prevent removal of the cartridge from the cartridge holder, so that the cartridge is permanently locked in the cartridge holder; the cartridge face is a proximal face facing away from the dispensing end of the cartridge; the cartridge face is disposed between the dispensing end of the cartridge and an end opposite the dispensing end; A cartridge assembly according to any preceding claim, wherein the locking feature is integrated into the cartridge holder.

5. the locking feature (322) protrudes radially from an inner wall of the cartridge holder (302), and the cartridge holder is configured to allow the locking feature to be elastically displaced radially; The cartridge assembly of claim 4 .

6. The cartridge assembly of claim 4 or 5, wherein the securing surface (324) includes a height facing toward the cartridge face.

7. A cartridge assembly according to any one of claims 4 to 6, wherein the fixing surface (324) is oriented relative to the cartridge surface (313) such that the surfaces face towards each other and are not parallel.

8. The cartridge assembly of any preceding claim, wherein the locking feature (322) comprises an area having a reduced thickness.

9. The cartridge-receiving section (303) includes at least three interior regions: a first region, a locking feature region, and a second region, and the locking feature (322) is the fixing feature region is disposed between the first region and the second region when viewed in the axial direction, and an inner diameter or clear span of the cartridge holder within the fixing feature region is smaller than an inner diameter or clear span within the first region and the second region, and the first region and the second region have different inner diameters or clear spans; A cartridge assembly according to any one of claims 1 to 8.

10. One of the first region or the second region includes a distal inner region disposed distally relative to the fixation feature, the distal inner region including two regions having two different inner diameters, the region having the smaller of the two different diameters being disposed distally relative to the region having the larger inner diameter; The cartridge assembly of claim 9.

11. The cartridge (301) includes a head portion (310) having a dosing end (306), a main body portion (311), a reduced diameter neck portion (312) disposed between the head portion and the main body portion, and a cartridge face (313) which is a surface axially bounding the head portion. A cartridge assembly according to any one of claims 1 to 10.

12. the cartridge holder (302) is radially closed along the entire angular or azimuthal extension of the locking feature and the entire axial extension of the locking feature (322); A cartridge assembly according to any one of claims 1 to 11.

13. 2. The cartridge assembly of claim 1, wherein the cartridge holder (302) includes, as an alternative to or cumulative with the region (350) having reduced mechanical stiffness, a region (355) having increased mechanical stiffness, the region (355) having increased mechanical stiffness being positioned adjacent to the fixing surface (324) in the proximal direction and reducing radial flexibility of the cartridge holder (302) in that region, thereby preventing proximal movement of the cartridge (301).

14. the locking feature (322) is integrally formed with a portion of the cartridge holder (302), which portion defines or forms an outer surface or outer contour of the cartridge holder in at least one region of the cartridge holder; A cartridge assembly according to any one of claims 1 to 13.

15. The locking feature (322) comprises a continuous mechanical interlock with the distal region (317) of the cartridge holder (302) in the circumferential direction; A cartridge assembly according to any preceding claim.

16. The region (350) having reduced mechanical stiffness is restricted to a region distal to the fixation feature (322); A cartridge assembly according to any preceding claim.

17. A drug delivery device (1) comprising a housing (10) and a cartridge assembly (300) according to any one of claims 1 to 16, wherein the cartridge assembly (300) is releasably coupled to the housing, and wherein the drug (307) contained in the cartridge is a medicament.

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