Drug delivery device, plunger rod, set of plunger rods, method of assembling a drug delivery device, and set of drug delivery devices

Abstract

The present invention relates to a drug delivery device (1000) including a housing (100) configured to receive a medicament container (8), with a stopper (82) sealing the medicament container proximally. The drug delivery device further includes a plunger rod (1) arranged axially movably relative to the housing and / or the medicament container, and a feedback mechanism operably coupled to the plunger rod. The drug delivery device has an initial state in which the plunger rod is in a start position. The drug delivery device is configured such that in the initial state, the plunger rod is axially spaced apart from the stopper when the medicament container is received within the housing. The drug delivery device is further configured such that the plunger rod is axially movable from its start position in a distal direction to a feedback position. Movement of the plunger rod in the distal direction enables the plunger rod to interact with the stopper and push the stopper distally, thus delivering the medicament contained within the medicament container. The feedback mechanism is triggered when the plunger rod reaches the feedback position. Triggering of the feedback mechanism produces an audible and / or tactile feedback to indicate the end of the medicament delivery. The present invention also relates to a plunger rod, a set of plunger rods, a set of drug delivery devices, and a method of assembling a drug delivery device.

Description

[Technical field]

[0001] A drug delivery device is provided. Additionally, a plunger rod, a set of plunger rods, a method of assembling a drug delivery device, and a set of drug delivery devices are provided. [Background technology]

[0002] Administering an injection is a process that poses many risks and challenges, both mental and physical, for users and medical personnel. Drug delivery devices may aim to make self-injection easier for patients. Traditional drug delivery devices may provide the force to administer the injection via a spring and trigger button, or another mechanism may be used to activate the injection. Drug delivery devices may be single-use or reusable devices.

[0003] There is a continuing need for improved drug delivery devices, methods of assembling such drug delivery devices, improved plunger rods and sets of plunger rods for such drug delivery devices, and sets of such drug delivery devices. Summary of the Invention [Problem to be solved by the invention]

[0004] One object to be achieved is to provide an improved drug delivery device. Further objects to be achieved are to provide a plunger rod for such a drug delivery device, an improved set of plunger rods for a drug delivery device, an improved set of drug delivery devices and an improved method for assembling a drug delivery device. These objects are achieved in particular by the subject matter of claims 1, 13, 14 and 15. Advantageous embodiments and further developments are subject to the dependent claims and are also presented in the following description and figures. [Means for solving the problem]

[0005] First, a drug delivery device is specified. The drug delivery device may be a single-use device and / or a disposable device.

[0006] According to at least one embodiment, the drug delivery device includes a housing configured to receive and / or hold the drug container by a stopper. The stopper can seal the drug container proximally, i.e. in the proximal direction. The drug delivery device can be configured to receive the drug container in the housing such that the drug container is axially and / or non-rotatably fixed relative to the housing. The drug delivery device can include a drug container holder that is a separate component from the housing and configured to receive and / or hold the drug container.

[0007] The housing may include or consist of plastic and / or may be integrally formed. The housing may be hollow and / or elongated and / or hollow cylindrical. The housing may be a sleeve. A longitudinal axis of the drug delivery device may extend through the center of the housing. The housing may be integrally formed, i.e., may be a unitary structure or may be integrally formed. The medicament container holder may be received within the housing. The medicament container holder may be axially and / or non-rotatably fixed relative to the housing. The medicament container holder may be integrally formed.

[0008] According to at least one embodiment, the drug delivery device includes a plunger rod arranged axially movable relative to the housing and / or the drug container. The plunger rod can be axially movable in only one axial direction or in two opposite axial directions. The plunger rod can be hollow or solid. The plunger rod can be cylindrical, for example hollow cylindrical. If the plunger rod is hollow, a further element or member can be received within the plunger rod, for example an energy member for driving the plunger rod. The plunger rod can include or consist of plastic. For example, the plunger rod is formed in one piece.

[0009] In this section and below, unless otherwise stated, movement of a member or element or feature is to be understood as movement relative to the housing.

[0010] For example, the plunger rod is received within the housing. The plunger rod can be circumferentially surrounded by the housing, e.g., completely surrounded in the circumferential direction. The housing can protrude distally and / or proximally beyond the plunger rod. The plunger rod can have a main extension direction parallel to a longitudinal axis of the drug delivery device. The longitudinal axis can extend through the plunger rod, e.g., through its center.

[0011] According to at least one embodiment, the drug delivery device includes a feedback mechanism operably coupled to the plunger rod. The feedback mechanism may be an audible and / or tactile feedback mechanism, in particular configured to indicate the end of the drug delivery process. The feedback mechanism may be operably coupled to the plunger rod such that a movement, e.g., an axial movement, of the plunger rod triggers the feedback mechanism. For example, the plunger rod may directly contact the feedback mechanism or an element / member / function thereof, respectively.

[0012] According to at least one embodiment, the drug delivery device has an initial state in which the plunger rod is in a start position. The start position can be a proximal-most position of the plunger rod. The initial state can be a state when the drug delivery device is delivered, i.e., when a user of the drug delivery device receives the drug delivery device. In other words, in the initial state, the drug delivery device is not activated.

[0013] According to at least one embodiment, the drug delivery device is configured such that, in an initial state, when the drug container is received in and / or held by the housing, the plunger rod is axially spaced from the stopper. Thus, in the initial state, a gap exists between the plunger rod and the stopper. This gap can compensate for manufacturing tolerances, assembly tolerances, and / or movement of the stopper during transportation. In other words, in all tolerance conditions, a gap exists between the plunger rod and the stopper. In particular, the plunger rod can then be positioned proximally offset with respect to the stopper. For example, in the initial state, the distal end of the plunger rod is spaced from the proximal end of the stopper. In the initial state, when the drug container is received in the housing, the stopper can also be in its respective starting position, which can be the most proximal position of the stopper. In the initial state, the distal end of the plunger rod can be positioned inside the drug container or outside the drug container.

[0014] According to at least one embodiment, the drug delivery device is configured such that the plunger rod is axially movable from its starting position in a distal direction to a feedback position, especially when starting from an initial state. The feedback position can be an end position of the plunger rod, or a position between the end position and the starting position. The feedback position and / or the end position can be located distally relative to the starting position. The end position can be the most distal position of the plunger rod when the drug delivery device is in use. If the feedback position is between the end position and the starting position, the feedback position is preferably located closer to the end position than the starting position.

[0015] According to at least one embodiment, the drug delivery device is configured such that movement of the plunger rod in a distal direction allows the plunger rod to interact with the stopper. The interaction may thus be such that, as the plunger rod is moved distally, the plunger rod pushes the stopper, for example, distally from its starting position. Preferably, movement of the stopper in the distal direction results in delivery of the drug contained within the drug container.

[0016] In other words, when the drug container is received within the housing, distal movement of the plunger rod can result in interaction between the plunger rod and the stopper such that that movement, or further movement of the plunger rod in the distal direction, pushes the stopper distally, delivering the drug contained within the drug container.

[0017] For example, the interaction between the plunger rod and the stopper can be a collision or abutment between the plunger rod and the stopper. For example, when the plunger rod interacts with the stopper, the distal end of the plunger rod directly contacts the proximal end of the stopper. The drug delivery device can be configured such that this interaction occurs before the plunger rod reaches the feedback position.

[0018] According to at least one embodiment, the drug delivery device is configured such that the feedback mechanism is triggered or activated, respectively, when the plunger rod reaches the feedback position. The feedback mechanism can be triggered by an operable connection between the plunger rod and the feedback mechanism. Preferably, the feedback mechanism is triggered or can be triggered only when the plunger rod is in the feedback position. The triggering of the feedback mechanism is automatic by the plunger rod reaching the feedback position.

[0019] According to at least one embodiment, the trigger of the feedback mechanism produces an audible and / or tactile feedback to indicate the end of drug delivery. The audible and / or tactile feedback can be particularly easily noticeable to a user of the drug delivery device. The feedback can provide a clear indication of the end of drug delivery. For example, the audible feedback is at least 70 dB, or at least 80 dB, or at least 90 dB.

[0020] In at least one embodiment, the drug delivery device includes a housing configured to receive the drug container, with a stopper proximally sealing the drug container. Additionally, the drug delivery device includes a plunger rod axially movably disposed relative to the housing and / or the drug container, and a feedback mechanism operably coupled to the plunger rod. The drug delivery device has an initial state in which the plunger rod is in a start position. The drug delivery device is configured such that in the initial state, the plunger rod is axially spaced apart from the stopper when the drug container is received within the housing. Additionally, the drug delivery device is configured such that the plunger rod is axially movable from its start position in a distal direction to a feedback position. Movement of the plunger rod in the distal direction enables the plunger rod to interact with the stopper and push the stopper distally, thus delivering the drug contained within the drug container. The feedback mechanism is triggered when the plunger rod reaches the feedback position. Triggering of the feedback mechanism produces an audible and / or tactile feedback to indicate an end of drug delivery.

[0021] The present invention is particularly based on the realization that manufacturing tolerances, for example in the position of the stopper, due to variations in the drug fill volume and / or variations in the length of the plunger rod, do not negatively affect the usefulness of the drug delivery device when the device is designed such that the plunger rod is intentionally axially spaced from the stopper in the initial state. Displacement of the stopper during transportation, for example due to changes in the drug volume and / or the volume of air bubbles in the cartridge due to changes in the ambient pressure, can also be accommodated by such spacing. In fact, contact between the plunger rod and the stopper before the intended use of drug delivery may lead to leakage during storage or release of the drug before the intended use.

[0022] The drug delivery device as specified herein may be elongated and / or may include a longitudinal axis, i.e., a main axis of extension. The axial direction may be a direction parallel to the longitudinal axis. By way of example, the drug delivery device may be cylindrical.

[0023] Furthermore, the drug delivery device may include an end, e.g., a longitudinal end, that may be provided to face or be pressed against a skin area of ​​the human body. This end is referred to herein as the distal end. A drug or agent may be delivered through this distal end. The opposite end is referred to herein as the proximal end. The proximal end is away from the skin area during use. The axial direction pointing from the proximal end to the distal end is referred to herein as the distal direction. The axial direction pointing from the distal end to the proximal end is referred to herein as the proximal direction. The distal end of a member or element or feature of a drug delivery device is understood herein to be the most distally disposed end of the member / element / feature. Correspondingly, the proximal end of a member or element or feature is understood herein to be the most proximally disposed end of the element / member / feature.

[0024] In other words, "distal" is used herein to designate a direction, end, or surface that is or will be arranged to face or point towards the dosing end of the drug delivery device or a component thereof and / or that points away from the proximal end, that will be arranged to face away from the proximal end, or that faces away from the proximal end. On the other hand, "proximal" is used herein to designate a direction, end, or surface that is or will be arranged to face or point away from the dosing end and / or the distal end of the drug delivery device or a component thereof. The distal end can be the end closest to the dosing end and / or the end furthest from the proximal end, and the proximal end can be the end furthest from the dosing end. The proximal face can face away from the distal end and / or towards the proximal end. The distal face can face towards the distal end and / or away from the proximal end. The dosing end can be, for example, the end of a needle, where a needle unit is attached or will be attached to the device.

[0025] Directions perpendicular to and / or intersecting the longitudinal axis are referred to herein as radial directions. Radially inward is a radial direction that points toward the longitudinal axis. Radially outward is a radial direction that points away from the longitudinal axis.

[0026] The terms "angular," "azimuthal," or "rotational" are used synonymously herein. Such directions are perpendicular to the longitudinal axis and perpendicular to the radial direction.

[0027] An element or member or feature being non-rotatably, axially or radially fixed relative to another element or member or feature means that relative rotational, axial or radial movement between the two elements / members / features is not possible or is prevented.

[0028] The terms "protrusion" and "boss" are used synonymously herein. The term "recess" can refer inter alia to a depression or cutout or opening or hole.

[0029] According to at least one embodiment, the drug delivery device is configured such that when the medicament container is received within the housing, the plunger rod is movable distally from its starting position a travel distance before interacting with the stopper, The drug delivery device may be configured in this manner, at least when started from an initial state.

[0030] For example, the plunger rod can be movable from its starting position a distance in the distal direction until an interaction position is reached. For example, during the movement of the plunger rod from the starting position to the interaction position, the stopper is not moved in the distal direction. Only when the interaction position is reached can an interaction between the plunger rod and the stopper begin. From there, further movement of the plunger rod in the distal direction can push the stopper in the distal direction. When the interaction position is reached, the plunger rod can hit and abut the stopper. In particular, the interaction position is axially located between the feedback position and the starting position, for example closer to the starting position than the feedback position.

[0031] According to at least one embodiment, initially, when the drug container is received and / or retained within the housing, the space between the plunger rod and the stopper is filled with gas, but preferably, this space is not sealed but is vented to atmosphere.

[0032] According to at least one embodiment, after being moved a travel distance and before reaching the feedback position, the plunger rod interacts with the stopper, in particular pushing the stopper in a distal direction.

[0033] According to at least one embodiment, the drug delivery device is configured such that, in an initial state, when the drug container is received in the housing, an initial distance between the plunger rod and the stopper is selected such that the probability of damage to the drug container when the plunger rod interacts with the stopper is reduced, e.g., damage is prevented. The initial distance can be equal to the travel distance.

[0034] When the plunger rod is moved distally from its starting position, it can strike the stopper with a certain force. The impact is transferred to the drug container. When the drug container can include glass, e.g. a cartridge formed from glass, the impact can lead to breakage of the glass. However, in the present invention, the initial distance between the plunger rod and the stopper is preferably selected, e.g. small, so that the risk of damage, e.g. breakage, of the drug container is reduced. However, the initial distance is selected to be large enough to allow compensation for manufacturing and transportation tolerances, as described above.

[0035] For example, the initial distance between the plunger rod and the stopper in the initial state is selected to prevent damage to the drug container when the plunger rod interacts with the stopper.

[0036] According to at least one embodiment, in the initial state, the initial distance between the plunger rod and the stopper is selected to take into account the variation of the distance due to manufacturing and / or assembly tolerances and / or vibrations occurring during transportation of the drug delivery device. This means that the space between the stopper and the plunger rod is predefined to absorb such variations. For example, the initial distance between the stopper and the plunger rod is selected such that even if one or more or all of these variations occur and / or converge, the minimum distance between the plunger rod and the stopper is still maintained, i.e., direct contact between the plunger rod and the stopper is prevented. For example, contact between the plunger rod and the stopper is only seen when switching from the initial state to the release state when the drug delivery device is activated.

[0037] The distance between the plunger rod and the stopper may be subject to certain variations. One reason for these variations may be the manufacturing tolerances of the drug delivery device, especially its components, such as the length of the plunger rod or the filling volume of the drug container. The filling volume affects the position of the stopper in the initial state. Variations may also occur during the assembly of the drug delivery device, for example due to variations in the compression of the drive spring of the drug delivery device. Furthermore, during the transportation of the device, the position of the stopper may change due to changes in the drug volume or the volume of the air bubble in the cartridge, induced for example by variations in the ambient pressure.

[0038] According to at least one embodiment, the feedback mechanism includes an indicator having a first state and a second state, the first state can be a biased state of the indicator and the second state can be a relaxed state of the indicator.

[0039] According to at least one embodiment, the drug delivery device is configured such that when the feedback mechanism is triggered or activated, the indicator switches from a first state to a second state. This switching can produce audible and / or tactile feedback. For example, in the first state, the indicator stores energy, which is released in the form of audible and / or tactile feedback when switching to the second state. For example, in the first state, the indicator is under tension and stores tension energy. In the first state, the indicator can be deformed to the second state.

[0040] When the indicator switches from the first state to the second state, the indicator may interact with a further feature or element or member of the drug delivery device, for example hitting the further feature or element or member of the drug delivery device, thereby producing audible and / or tactile feedback.

[0041] According to at least one embodiment, in an initial state, the indicator is in the first state. Alternatively, the indicator can transition from, for example, the second state to the first state when the plunger rod is moved distally from its starting position, and then switch back to the first state when the plunger rod reaches the feedback position.

[0042] According to at least one embodiment, the indicator includes or is a resilient element or member. For example, the indicator includes or is a spring, such as a leaf spring. The indicator can include or consist of metal or plastic, such as a metal sheet. The indicator can be a monostable or bistable spring element.

[0043] According to at least one embodiment, the indicator is bent at a specific angle about the longitudinal axis to form a longitudinal round fold and has two adjacent inclined vane-like sections disposed on either side of the longitudinal round fold. The indicator may further include a notch in the longitudinal round fold. The notch may extend transversely to the longitudinal round fold. The notch may be centrally disposed within the longitudinal round fold. The indicator may include a support tab, for example in the vane-like section. The support tab may protrude outwardly from the vane-like section. The longitudinal round fold may have a bend radius of 0.5 mm to 5 mm, preferably 1.5 mm to 2 mm, inclusive. The indicator may have a rectangular shape, a square shape, or an elliptical shape.

[0044] According to at least one embodiment, the feedback mechanism includes a trigger feature. The trigger feature can be part of the plunger rod, e.g., integrally formed with the body of the plunger rod. The trigger feature can be axially and / or non-rotatably fixed relative to the plunger rod.

[0045] According to at least one embodiment, the feedback mechanism includes an operating feature. The operating feature may be axially and / or non-rotatably fixed relative to the housing. The operating feature may be part of the indicator, e.g., may be integrally formed with the indicator, or may be part of a further element or member of the feedback mechanism.

[0046] According to at least one embodiment, at least one of the trigger function and the operating function is displaceable, i.e., a displaceable function. For example, the displaceable function is radially displaceable. The other function can also be radially fixed relative to the plunger rod or the housing, respectively. The displaceable feature can be fixed to the displaceable element or can be part of the displaceable element, e.g. a flexible or pivotable or elastic element, e.g. a flexible or pivotable or elastic arm. The displaceable element can be part of the plunger rod or can be axially and / or non-rotatably fixed relative to the housing. For example, the displaceable element is axially oriented. The displaceable element can be elongated, e.g. having a main extension direction along the longitudinal axis. The displaceable feature can be located at the distal end of the displaceable element or can be located closer to the distal end than the proximal end of the displaceable element. The distal end of the displaceable arm can be displaceable, and the proximal end of the displaceable arm can be radially fixed relative to the housing.

[0047] According to at least one embodiment, the drug delivery device is configured such that when the plunger rod is moved from its starting position to the feedback position, the trigger feature and the operating feature axially pass each other or at least axially and / or non-rotatably overlap each other, thereby allowing the displaceable feature to be displaced and trigger the feedback mechanism. The drug delivery device can be configured in this way at least when starting from an initial state. Displacement of the displaceable feature can trigger the feedback mechanism or enable triggering of the feedback mechanism. The trigger feature and the operating feature can engage each other when axially and / or non-rotatably overlap each other. For example, displacement of the displaceable feature enables or involves a transition of the indicator from a first state to a second state.

[0048] For example, when the plunger rod is moved distally starting from its starting position and reaches the feedback position, the trigger feature and the operating feature pass each other or at least axially and / or non-rotatably overlap each other, such that the displaceable feature is displaced and the feedback mechanism is triggered.

[0049] According to at least one embodiment, the displaceable feature is held in a first position before the feedback mechanism is triggered, e.g., before the plunger rod reaches the feedback position. In the first position, the displaceable feature can be biased toward the second position, e.g., in a radially inward or radially outward direction. The first position and the second position can be radially displaceable relative to one another.

[0050] According to at least one embodiment, the displaceable feature displaces from the first position to the second position when the plunger rod reaches the feedback position, which can occur automatically, for example when the displaceable feature is biased in the first position toward the second position.

[0051] According to at least one embodiment, the operating feature is displaceable, for example radially. The plunger rod can hold the displaceable operating feature in its first position when the plunger rod is in a position proximal to the feedback position. For example, the displaceable operating feature can abut radially against a surface, for example an outer surface, of the plunger rod. This abutment can hold the displaceable operating feature in the first position. For example, the displaceable operating feature is held in the first position as long as the plunger rod is between the start position and the feedback position.

[0052] Alternatively, the trigger feature may be displaceable, for example radially. The displaceable trigger feature may abut a surface that is axially and / or non-rotatably fixed relative to the housing when the plunger rod is in a position proximal to the feedback position.

[0053] The displaceable feature may also be guided from the first position to the second position by a guiding feature, e.g., a ramp or rail, when the plunger rod reaches the feedback position, in which case the displaceable feature may or may not be biased toward the second position when in the first position.

[0054] According to at least one embodiment, the operating feature is a protrusion, e.g., a radially protruding protrusion. For example, the protrusion protrudes in a radially inward or radially outward direction from the displaceable element. The protrusion can have the shape of a fin. For example, the protrusion includes a distal edge or face facing in a distal direction and a proximal edge or face facing in a proximal direction. The distal edge or face can be steeper than the proximal edge or face, e.g., as measured relative to the longitudinal axis.

[0055] According to at least one embodiment, the trigger feature is a recess in the plunger rod. The recess can be elongated, for example with a main extension direction parallel to the main extension direction of the plunger rod and / or parallel to the longitudinal axis. The recess can be a groove or a cutout. The recess can be located in a side surface of the plunger rod. The recess can extend in the plunger rod from the side surface towards or into the cavity. The recess can be delimited in the distal and / or proximal direction by an edge of the plunger rod. It is also possible that the recess is only delimited in the distal direction by such an edge and opens in the proximal direction. In this case, the recess can extend to the proximal end of the plunger rod.

[0056] According to at least one embodiment, the trigger feature is a proximal end of the plunger rod, for example a proximally facing surface of the plunger rod.

[0057] It is also possible that the trigger feature is the protrusion specified above and the operating feature is the recess specified above.

[0058] According to at least one embodiment, when the plunger rod reaches the feedback position, the protrusion is displaced into the recess or into a space proximally rearward of the proximal end of the plunger rod, in particular the recess and the protrusion are dimensioned to allow engagement between these two features.

[0059] According to at least one embodiment, the feedback mechanism includes a support element. The support element can provide mechanical support for the indicator to hold the indicator in the first state until the plunger rod reaches the feedback position. For example, when the support element provides mechanical support, the support element and the indicator are in direct contact.

[0060] According to at least one embodiment, the mechanical support holding the indicator in the first state is released or eliminated when the plunger rod reaches the feedback position, thus allowing the indicator to switch to the second state. In other words, when the plunger rod reaches the feedback position, the support element no longer holds the indicator in the first state, thus allowing the indicator to switch or be switched to the second state. When the indicator is in the second state, the support element can hold the indicator again.

[0061] The support element can be axially and / or non-rotatably fixed relative to the housing. The support element can be part of a member or element that is axially and / or non-rotatably fixed relative to the housing, such as an energy member holder or a drive spring holder, respectively. The support element can be or include a displaceable element as described above. The displaceable feature can be part of the displaceable element. In this sense, the displacement of the displaceable element can be correlated with the displacement of the displaceable feature and vice versa.

[0062] For example, when the plunger rod is in a position proximal to the feedback position, the displaceable element is held in a first position. The first position can be a biased position in which the displaceable element is biased toward the second position, e.g., in a radially inward or radially outward direction. When the plunger rod reaches the feedback position, the displaceable element can be allowed to displace to the second position.

[0063] According to at least one embodiment, the operating feature is fixed to or is part of the support element.

[0064] According to at least one embodiment, the indicator is axially and / or non-rotatably fixed relative to the housing.

[0065] According to at least one embodiment, the plunger rod is rotatably disposed relative to the housing. The axis of rotation of the plunger rod can define the longitudinal axis or can be coincident with the longitudinal axis.

[0066] According to at least one embodiment, in an initial state, the plunger rod is coupled to the housing by an axial locking interface that prevents axial movement of the plunger rod in a distal direction. The axial locking interface can be formed directly between the plunger rod and the housing, or directly between the plunger rod and a member / element axially fixed to the housing, such as a drive spring holder.

[0067] According to at least one embodiment, the drug delivery device is configured such that rotation of the plunger rod relative to the housing releases an axial locking interface to enable movement of the plunger rod in a distal direction, for example, the plunger rod must be rotated at least 5° to release the axial locking interface.

[0068] According to at least one embodiment, the plunger rod includes a retention structure. The retention structure can be located in a region of the proximal end of the plunger rod, for example closer to the proximal end than the distal end. The retention structure can include one or more retention features. The retention structure can include two or more retention features that are rotationally and / or axially offset with respect to each other. For example, the retention structure includes at least two or at least four or at least six retention features. Each retention feature can be a protrusion, for example a protrusion that protrudes in a radially outward direction from the body of the plunger rod. The protrusion can protrude in a radially outward direction from a side of the plunger rod.

[0069] According to at least one embodiment, the drug delivery device includes an axial locking feature that is axially and / or non-rotatably fixed relative to the housing. The axial locking feature can be part of the housing or the drive spring holder. The axial locking feature can be a recess.

[0070] According to at least one embodiment, in an initial state, the retaining structure, in particular its at least one retaining feature, and the axial locking feature interact or engage with one another such that an axial locking interface is established, e.g., a protrusion of the retaining structure projects into the recess and abuts an edge distally bounding the recess, thereby preventing axial movement of the plunger rod.

[0071] According to at least one embodiment, rotation of the plunger rod disengages the interaction or engagement between the retaining structure and the axial locking feature.

[0072] According to at least one embodiment, the drug delivery device includes a drug container. The drug container can include a needle. The drug container can be received within the housing, e.g., can be circumferentially surrounded by the housing. The needle can form a distal end of the drug container. The drug container can be axially and / or non-rotatably fixedly disposed relative to the housing, e.g., not moved relative to the housing during intended use of the drug delivery device. Alternatively, the drug container can be movable relative to the housing, and can be moved relative to the housing during intended use of the drug delivery device.

[0073] The drug container may be a syringe, e.g. a pre-filled syringe. The drug container may comprise glass. The drug container may be proximally sealed by a stopper, i.e. an end of the drug container opposite the needle is sealed closed by the stopper. The drug container may comprise a drug or agent, e.g. a liquid drug or agent. The stopper may contact the agent. The drug delivery device may be configured to empty the drug container when the drug delivery process is performed. For example, the drug container contains an amount of drug sufficient for just one drug delivery operation.

[0074] According to at least one embodiment, the drug delivery device is an auto-injector.

[0075] According to at least one embodiment, the drug delivery device includes an energy member configured to provide energy for inducing axial movement of the plunger rod in a distal direction. The energy member can be a drive spring, e.g., a compression spring, or another component configured to induce axial movement of the plunger rod, e.g., a gas cartridge or an electric motor. The drive spring can be formed of a metal, e.g., steel. The longitudinal axis can extend through a center of the drive spring. The energy member can be received in a housing. The drive spring can be received in a cavity of the plunger rod.

[0076] According to at least one embodiment, the drug delivery device is configured to be switched from an initial state to a released state, in which the plunger rod moves in a distal direction by energy provided by an energy member. For example, in the initial state, the drive spring can be biased, e.g., compressed, and can further bias the plunger rod in a distal direction. In the released state, the biased drive spring can be released, transferring energy to the plunger rod and moving the plunger rod in a distal direction. Release of the axial locking interface can result in switching from the initial state to the released state.

[0077] The distal end of the drive spring can abut or be secured to a proximally facing surface of the plunger rod, and the proximal end of the drive spring can abut or be secured to a housing or drive spring holder.

[0078] According to at least one embodiment, the drug delivery device includes a release member, e.g., a needle shroud, disposed axially movably relative to the housing. The release member can be received within the housing. The release member can be telescopically coupled to the housing. The release member can be non-rotatably fixed to the housing.

[0079] According to at least one embodiment, when the drug delivery device is in an initial state, movement of the release member in an axial direction, e.g., a proximal direction, enables rotation of the plunger rod to release the axial locking interface. For example, in the initial state, the plunger rod is coupled to the housing by a rotation locking interface, which prevents rotation of the plunger rod relative to the housing. Movement of the release member in an axial direction can release the rotation locking interface to enable rotation of the plunger rod.

[0080] For example, in the initial state, the plunger rod is biased in a rotational direction but is prevented from rotating by the rotation lock interface. After disengagement of the rotation lock interface, the plunger rod can rotate automatically, thereby disengaging the axial lock interface. The rotation lock interface can be formed directly between the release member and the plunger rod. For example, the release member includes a rotation lock feature that, in the initial state, interacts or engages with a retaining structure of the plunger rod, such as at least one retaining feature thereof, thereby establishing the rotation lock interface. Axial movement of the release member can disengage this interaction or engagement.

[0081] The rotation locking feature of the release member may be a recess in the release member into which a protrusion of the retaining structure protrudes. The recess may be L-shaped. The protrusion may abut an edge of the recess that rotationally bounds the recess, thereby preventing rotation of the plunger rod. When the release member is moved axially, the edge of the recess may be displaced against the protrusion of the retaining structure, thus enabling rotation of the plunger rod.

[0082] According to at least one embodiment, in an initial state, the release member is in an extended position and covers a drug delivery element of the medicament container. The drug delivery element can be a needle or a cannula. For example, in the initial state, when the medicament container is received in the housing, the release member protrudes distally beyond the drug delivery element. In the extended position, the release member can protrude distally beyond the housing. At least a distal region of the release member can be sleeve-like.

[0083] According to at least one embodiment, movement of the release member in an axial, e.g., proximal, direction to a retracted position effects rotation of the plunger rod to release the axial locking interface.

[0084] According to at least one embodiment, the retracted position of the release member is a position that exposes the drug delivery element. Thus, when the drug container is received in the housing and the release member is in the retracted position, the drug delivery element is exposed. For example, when the release member is in the retracted position, the drug delivery element protrudes distally beyond the release member.

[0085] According to at least one embodiment, the drug delivery device includes a shroud spring. The shroud spring can be coupled to the release member and the housing. The shroud spring can be configured to induce a restoring force acting axially, e.g., in a distal direction, on the release member when the release member is moved from the extended position toward the retracted position.

[0086] The drug delivery device can be used as follows: First, the drug delivery device is in its initial state. Then, a user presses the distal end of the drug delivery device against a body, e.g., a skin area of ​​a human body. In this state, the distal end of the drug delivery device can be formed by the distal end of the release member. This moves the release member from the extended position to the retracted position. This movement biases the shroud spring, which biases the release member in a distal direction relative to the housing. In the retracted position, the rotational locking interface is released. As a result, the plunger rod rotates, thereby releasing the axial locking interface, and thus the drug delivery device switches to the released state. In the released state, the plunger rod can first move distally without pushing the stopper distally. The plunger rod then interacts with the stopper to push it distally, and thus the drug is delivered, e.g., injected into the tissue of the body. At or near the end position, the plunger rod reaches a feedback position, thereby triggering the feedback mechanism and generating audible and / or tactile feedback. This notifies the user that the drug delivery process is complete. The user can then remove the distal end of the drug delivery device from the skin. The shroud spring urges the release member distally, e.g., back to the extended position.

[0087] Next, a plunger rod for the drug delivery device is specified. The plunger rod can be the plunger rod of the above specified drug delivery device. Thus, all configurations disclosed in relation to the plunger rod of the above specified drug delivery device are also disclosed for the below specified plunger rod and vice versa.

[0088] According to at least one embodiment, the plunger rod includes a trigger feature configured to enable triggering of an audible and / or tactile feedback mechanism of the drug delivery device when the plunger rod is assembled into the drug delivery device and the trigger feature axially passes through or at least axially overlaps the operating feature of the feedback mechanism.

[0089] According to at least one embodiment, the plunger rod includes a retaining structure configured to interact with an axial locking feature of the drug delivery device to establish an axial locking interface that prevents axial movement of the plunger rod relative to the housing of the drug delivery device in at least one axial direction, e.g., the distal direction. The retaining structure can also be configured to interact with a rotational locking feature of, e.g., the release member, to establish a rotational locking interface that prevents rotation of the plunger rod relative to the housing and / or release member of the drug delivery device.

[0090] According to at least one embodiment, the trigger feature is a proximal end of the plunger rod and / or does not axially overlap the retaining structure and / or protrudes proximally beyond the retaining structure.

[0091] The region of the retention structure can be defined by the retention feature of the retention structure. For example, the distal end of the retention structure can be defined by the most distally disposed retention feature or by the distal end of the retention feature, respectively. The proximal end of the retention structure can be defined by the most proximally disposed retention feature or by the proximal end of the retention feature, respectively.

[0092] Next, a set of plunger rods for a drug delivery device is specified. The set includes a plurality of plunger rods, for example at least two or at least four or at least six. All configurations disclosed in relation to the plunger rods of the above-mentioned drug delivery device or the above-mentioned plunger rods are also disclosed for the plunger rods of the set of plunger rods, and vice versa. In particular, the plunger rods of the set of plunger rods described below can be used in the above-mentioned drug delivery device.

[0093] According to at least one embodiment, each plunger rod of the set of plunger rods includes a trigger feature configured to enable triggering of an audible and / or tactile feedback mechanism of the drug delivery device when the plunger rod is assembled into the drug delivery device and the trigger feature axially passes through or at least axially overlaps the operating feature of the feedback mechanism.

[0094] According to at least one embodiment, each plunger rod of the set of plunger rods has a distal end. The distal end is particularly configured to interact with a stopper of the drug container. The distal end is particularly configured to face towards the stopper of the drug container. Preferably, each distal end of each plunger rod of the set of plunger rods is configured to interact with a stopper of the drug container when the drug delivery device is activated. As a result, the drug delivery device and / or at least one plunger rod of the set of plunger rods are configured such that in an initial state of the drug delivery device, there is a gap between at least one plunger rod of the set of plunger rods and the stopper for all combinations of plunger rods and drug containers.

[0095] According to at least one embodiment, at least some of the plunger rods of the set of plunger rods have different lengths. For example, the lengths vary by at least 10% or at least 20% or at least 50% around an average length averaged over all the plunger rods of the set of plunger rods. For example, the different length plunger rods deviate in length by at least 10% or at least 20% and / or at least 5 mm or at least 10 mm.

[0096] According to at least one embodiment, the distance between the distal end and the trigger feature is the same or substantially the same for all plunger rods of the set of plunger rods, for example measured from the distal end of the plunger rod to the distal end of the trigger feature.

[0097] In this chapter and below, "substantially the same" means that, for example, a deviation of at most 5% or at most 2% or at most 1% from the mean value may occur. The mean value may be averaged over all members of the respective set. Furthermore, when two elements, members or functions are claimed to be the same or substantially the same, this may also mean that the materials are the same.

[0098] Since the distance between the distal end and the trigger feature is the same or substantially the same for all plunger rods, most components of the drug delivery device, such as the housing, the operating feature, the release member, etc., do not need to be replaced when changing the length of the plunger rod. When changing the fill volume of the drug contained in the drug container, the length of the plunger rod needs to be changed. In fact, the feedback mechanism triggers or activates regardless of the length of the plunger rod.

[0099] According to at least one embodiment, each of the plunger rods of the set of plunger rods includes a retention feature. The retention feature can be the same or substantially the same for all of the plunger rods. For example, the axial and / or rotational positions of the retention features relative to one another and / or the dimensions of the retention features are the same or substantially the same for all of the plunger rods.

[0100] In this chapter and below, the location of a member, element or feature may be defined by the location of its respective centre, for example the centre of gravity.

[0101] Next, a method for assembling the drug delivery device is specified. In particular, the above specified drug delivery device can be assembled by the method described below. Thus, all features disclosed in relation to the drug delivery device are also disclosed for this method and vice versa.

[0102] According to at least one embodiment, the method includes providing a medicament container containing a medicament. The medicament occupies a fill volume within the medicament container. For example, the fill volume or amount of the medicament is between 0.5 mL and 2 mL, respectively, inclusive. The medicament container can include a stopper that proximally seals the medicament container. The stopper can be formed from rubber and / or can be integrally formed.

[0103] According to at least one embodiment, the method includes selecting a plunger rod from the set of plunger rods depending on the fill volume or amount of the drug, respectively. In particular, depending on the fill volume, the length of the plunger rod is selected. For example, the smaller the fill volume, the larger the length of the plunger rod is selected.

[0104] According to at least one embodiment, the method includes a step in which a drug delivery device is assembled by using a drug container and a selected plunger rod.

[0105] According to at least one embodiment, the provided drug container is selected from a set of drug containers including a plurality of drug containers. At least some of the drug containers can contain drugs occupying different filling volumes, i.e. can contain different amounts of drug. The geometry or dimensions of the different drug containers can be the same or substantially the same for all drug containers. Only the amount of drug and, accordingly, the position of the stopper can differ in the different drug containers.

[0106] Next, a set of drug delivery devices is specified. The set includes a plurality of drug delivery devices, for example at least two or at least four or at least six. Each drug delivery device can be assembled by the method specified above. Thus, all configurations disclosed in relation to this method are also disclosed for the drug delivery devices of the set of drug delivery devices, and vice versa.

[0107] According to at least one embodiment, each drug delivery device of the set of drug delivery devices includes a plunger rod, which can be one of the plunger rods specified above, such as one of the set of plunger rods.

[0108] According to at least one embodiment, each drug delivery device of the set of drug delivery devices includes an audible and / or tactile feedback mechanism having an operating function. Preferably, the operating function is the same or substantially the same for all drug delivery devices. The feedback mechanism may in each case include an indicator. The indicator may also be the same or substantially the same for all drug delivery devices.

[0109] According to at least one embodiment, each drug delivery device of the set of drug delivery devices includes a container-retaining area. The container-retaining area can be an area configured to hold or receive a drug container of the drug delivery device.

[0110] For example, the drug delivery device includes at least one container holder element configured to abut, for example, in a proximal or distal direction, against a drug container or a drug container holder holding the drug container. For example, the container holder element can be configured to abut a flange of the drug container. The container holder element can be configured to prevent the drug container and / or the drug container holder from axial and / or rotational movement relative to the container holding area or the housing, respectively. The container holder element can be the same or substantially the same in all drug delivery devices. The container holder element can be part of the housing, for example integrally formed with the housing. For example, the dimensions of the container holder element and / or the position of the container holder element relative to the housing can be the same or substantially the same in all drug delivery devices.

[0111] The container-holding area, in particular the container holder element, can be fixed axially and / or non-rotatably relative to the housing. For example, the container-holding area can be defined by the area between the most proximal and most distal container holder elements, or can be the area from the most proximal container holder element of the housing to the distal end of the housing. If the drug delivery device includes a medicament container holder, the container-holding area can also be defined by an extension of this medicament container holder.

[0112] According to at least one embodiment, at least some of the plunger rods of the different drug delivery devices have different lengths. Accordingly, when the drug delivery devices include drug containers, at least some of the drug containers of the drug delivery devices can include drugs that occupy different fill volumes within the drug containers.

[0113] The dimensions of the drug containers of the different drug delivery devices and / or their location within the housing can be the same or substantially the same for all drug delivery devices. The materials used can also be the same or substantially the same.

[0114] According to at least one embodiment, the location of the operating feature relative to the container-retaining area is the same or substantially the same for each drug delivery device of the plurality of drug delivery devices. The location of the container-retaining area can be at the center or a distal end or a proximal end of the container-retaining area.

[0115] Hereinafter, the drug delivery device described herein, the plunger rod described herein, the set of plunger rods described herein, the set of drug delivery devices described herein, and the method of assembling the drug delivery device described herein will be described in more detail with reference to the drawings based on exemplary embodiments. In each figure, the same reference numerals indicate the same elements. However, the relevant size ratios are not necessarily in proportion to the original size, and each element may be shown with rather exaggerated size for better understanding. [Brief description of the drawings]

[0116] [Figure 1] 1A-1C show a first exemplary embodiment of a drug delivery device in different views and in different positions during use of the drug delivery device. [Diagram 2] 1A-1C show a first exemplary embodiment of a drug delivery device in different views and in different positions during use of the drug delivery device. [Diagram 3] 1A-1C show a first exemplary embodiment of a drug delivery device in different views and in different positions during use of the drug delivery device. [Figure 4] 1A-1C show a first exemplary embodiment of a drug delivery device in different views and in different positions during use of the drug delivery device. [Diagram 5] 1A-1C show a first exemplary embodiment of a drug delivery device in different views and in different positions during use of the drug delivery device. [Figure 6] 1A-1C show a first exemplary embodiment of a drug delivery device in different views and in different positions during use of the drug delivery device. [Figure 7] 1A-1C show a first exemplary embodiment of a drug delivery device in different views and in different positions during use of the drug delivery device. [Figure 8] 1A-1C show a first exemplary embodiment of a drug delivery device in different views and in different positions during use of the drug delivery device. [Figure 9] 1A-1C show a first exemplary embodiment of a drug delivery device in different views and in different positions during use of the drug delivery device. [Figure 10] 1A-1C show a first exemplary embodiment of a drug delivery device in different views and in different positions during use of the drug delivery device. [Figure 11] 13A-13D show a second exemplary embodiment of a drug delivery device in different views and in different positions during use of the drug delivery device. [Figure 12]13A-13D show a second exemplary embodiment of a drug delivery device in different views and in different positions during use of the drug delivery device. [Figure 13] 13A-13D show a second exemplary embodiment of a drug delivery device in different views and in different positions during use of the drug delivery device. [Figure 14] 13A-13D show a second exemplary embodiment of a drug delivery device in different views and in different positions during use of the drug delivery device. [Figure 15] 13A-13D show a third exemplary embodiment of a drug delivery device in different views and in different positions during use of the drug delivery device. [Figure 16] 13A-13D show a third exemplary embodiment of a drug delivery device in different views and in different positions during use of the drug delivery device. [Figure 17] 13A-13D show a third exemplary embodiment of a drug delivery device in different views and in different positions during use of the drug delivery device. [Figure 18] 13A-13D show a third exemplary embodiment of a drug delivery device in different views and in different positions during use of the drug delivery device. [Figure 19] 1A-1C illustrate an exemplary embodiment of an indicator in different states. [Figure 20] 1A-1C illustrate an exemplary embodiment of an indicator in different states. [Figure 21] 1A-1C illustrate a portion of an exemplary embodiment of a plunger rod. [Figure 22] 1 illustrates a portion of an exemplary embodiment of a release member. [Figure 23] 1A-1C show an exemplary embodiment of a method for assembling a drug delivery device, as well as an exemplary embodiment of a set of plunger rods, and an exemplary embodiment of a set of drug delivery devices. [Figure 24] 13A-13C show further exemplary embodiments of a set of plunger rods. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0117] Figures 1 and 2 show side views of a first exemplary embodiment of a drug delivery device 1000. Figure 1 shows a first view of the drug delivery device 1000 and Figure 2 shows a second view in which the device 1000 is rotated 90° about the longitudinal axis A compared to the first view.

[0118] 1 and 2 also show the coordinate system used herein to specify the location of members or elements or functions. The distal direction D and the proximal direction P run parallel to the longitudinal axis A. The longitudinal axis A is the main axis of extension of the device 1000. The radial direction R is a direction perpendicular to and intersecting the longitudinal axis A. The azimuthal direction C, also called the angular or rotational direction, is a direction perpendicular to the radial direction R and the longitudinal axis A. To increase the clarity of these figures, the different directions and axes are not shown in all of the following figures.

[0119] The drug delivery device 1000 according to the first exemplary embodiment is an auto-injector. The auto-injector 1000 includes a housing 100. A cap 110 is removably attached or coupled to the housing 100 at a distal end of the housing 100. The housing 100 can be formed in one piece and can extend from the cap 110 to a proximal end of the auto-injector 1000. The housing 100 is a cylindrical sleeve.

[0120] 1 and 2, the housing 100 includes a window 120 through which a drug container within the housing 100 can be viewed. For example, the fill level of a drug within the drug container or the advancement of a stopper within the drug container, or the transparency of the drug or degradation of the drug can be observed through the window 120.

[0121] 3 and 4 show the auto-injector 1000 in the same view as in FIGS. 1 and 2, but now in cross section, with the cap 110 removed from the housing 100. A drug container 8 in the form of a syringe 8 is received in the housing 100, i.e. in the container holding area 6. In one embodiment, a flange 8a is arranged in the proximal part of the syringe 8, for example at the proximal end of the syringe 8. The flange 8a can project radially from the syringe 8, for example from the barrel of the syringe. The syringe 8 is held in a drug container holder 6c, also called syringe holder 6c. Container holder elements 6a, 6b are provided and are axially and non-rotatably fixed to the housing 100. The container holder elements 6a, 6b abut against the flange 8a of the syringe 8 and / or the distal end of the syringe holder 6c. In this manner, the syringe 8 is axially, preferably non-rotatably, supported or fixed to the housing 100. As a result, the syringe 8 is not moved distally relative to the housing 100 during needle insertion and / or delivery operations. The container holder element 6a is integrally formed with the housing 100. In other embodiments, a separate container holder can be provided.

[0122] The syringe 8 includes a cartridge 81 (or barrel) filled with a drug. The syringe 8 is sealed in a proximal direction P by a stopper 82. The syringe 8 further includes a needle 80 at a distal end of the drug container 8. The needle 80 is fluidly coupled to the cartridge 81. Movement of the stopper 82 in a distal direction D forces the drug in the cartridge 81 out of the needle 80. The cartridge may be formed from glass. The stopper 82 may be formed from rubber and / or may be formed in one piece.

[0123] The plunger rod 1 is received within the housing 100. The plunger rod 1 is disposed in a proximal offset relation to the stopper 82. The distal end of the plunger rod 1 projects into the syringe 8, in particular into the cartridge 81, and faces the stopper 82.

[0124] 3 and 4 show the auto-injector 1000 in an initial state. In the initial state, the plunger rod 1 is spaced apart from the stopper 82, taking into account, inter alia, manufacturing tolerances, assembly tolerances, and / or movements of the stopper 82 during transportation. In the initial state, the distal end of the plunger rod 1 can be located within the syringe 8 (see FIG. 3) or outside the syringe 8 (not explicitly shown). In the initial state, the distal end of the plunger rod 1 can be proximally offset from the proximal end of the stopper 82. Preferably, the auto-injector 1000 and / or the plunger rod 1 are designed to ensure that in the initial state in all tolerance conditions, there is a distance between the plunger rod 1, preferably its distal end, and the stopper 82, preferably its proximal end.

[0125] The plunger rod 1 is biased in the distal direction D by a drive spring 3 (see, for example, FIGS. 7 to 10). The drive spring 3 is a compression spring that is compressed in an initial state and presses the plunger rod 1 to move it in the distal direction D. However, in the initial state, the plunger rod 1 is connected to the housing 100 by an axial lock interface, so that distal movement of the plunger rod 1 is prevented.

[0126] An axial locking interface is established between the plunger rod 1 and the drive spring holder 4. The drive spring holder 4 is axially, preferably non-rotatably, fixed relative to the housing 100. The plunger rod 1 has a retaining structure 14, which includes protrusions 10. The protrusions 10 protrude in a radially outward direction from the body of the plunger rod 1. In an initial state, the protrusions 10 protrude or engage into recesses 24 of the drive spring holder 4, respectively, and abut against edges that delimit the recesses 24 in a distal direction D. In this way, an axial locking interface is established and the plunger rod 1 is prevented from movement in the distal direction D induced by the drive spring 3.

[0127] As can be further seen in Figures 3 and 4, the drive spring holder 4 comprises a support element 22 in the form of a resilient arm 22. The resilient arm 22 is axially oriented and radially displaceable. The proximal end of the resilient arm 22 is fixed to the body of the drive spring holder 4, while the distal end of the resilient arm 22 is radially displaceable. An operating feature 23 in the form of a protrusion 23 is arranged at the distal end of the resilient arm 22 and protrudes in a radially inward direction from the resilient arm 22. The protrusion 23 abuts against the outer surface, i.e. the side surface, of the plunger rod 1. In Figures 3 and 4, the resilient arm 22 and the protrusion 23 are in a first radial position and are biased in a radially inward direction. The resilient arm 22 with the protrusion 23 is held in the first radial position by abutment against the plunger rod 1.

[0128] The resilient arm 22 supports and holds the indicator 21 in the form of a leaf spring 21 in a first or biased state, respectively. FIG. 20 shows the leaf spring 21 in detail in the biased state. The indicator 21 is configured to switch from a first state to a second state, which may be a relaxed state. The indicator 21 in the relaxed state is shown in FIG. 19. When switching from the first state to the second state, the indicator 21 generates an audible and / or tactile feedback due to the release of energy. However, in the initial state shown in FIGS. 3 and 4, the support element 22 is held in the first position, thereby holding the indicator 21 in the first state, thereby preventing the indicator 21 from switching from the first state to the second state. The indicator 21 and the resilient arm 22 together with the protrusion 23 are part of an audible and / or tactile feedback mechanism operably connected to the plunger rod 1.

[0129] 3 and 4, the auto-injector 1000 includes a release member 5 in the form of a needle shroud 5. The needle shroud 5 is received within and matingly coupled to the housing 100. In an initial state, the needle shroud 5 is in an extended position and projects distally from the housing 100 beyond the needle 80, thereby covering the needle 80.

[0130] The needle shroud 5 in the extended position is connected to the plunger rod 1 via a rotation locking interface that prevents rotation of the plunger rod 1 relative to the release member 5 or the housing 100, respectively. As explained below, rotation of the plunger rod 1 should release the axial locking interface. In practice, the plunger rod 1 can be biased in a rotational direction, for example, by the drive spring 3 pressing the plunger rod 1 in the distal direction D against an inclined surface of the drive spring holder 4, which in turn induces a torque on the plunger rod 1. In this exemplary embodiment, the inclined surface delimits the recess 24 in the distal direction, against which the protrusion 10 presses.

[0131] In FIG. 4 it can be seen that the drive spring holder 4 actually comprises two separate support elements 22 each in the form of a resilient arm 22 .

[0132] Figures 5 and 6 show the auto-injector 1000 in the same view as Figures 3 and 4, but in a position in which the auto-injector 1000 is in use. The distal end of the auto-injector 1000 is pressed against, for example, the injection side of a skin area of ​​the body. This causes the needle shroud 5 to move in a proximal direction P relative to the housing 100 to a retracted position, thereby exposing the needle 80. The needle 80 is then penetrated, for example, into the tissue of the body.

[0133] Movement of the needle shroud 5 in the retracted position releases the rotational locking interface. The plunger rod 1 rotates automatically when biased in a rotational direction. This releases the axial locking interface as the protrusions 10 disengage from the recesses 24. Movement of the plunger rod 1 in the distal direction D is now unhindered. The auto-injector 1000 is now in a released state.

[0134] 6, the plunger rod 1 includes two trigger features 13, each in the form of a recess or cutout in the plunger rod 1. Rotation of the plunger rod 1 now causes the recesses 13 to rotationally align with the protrusions 23.

[0135] Figures 7 and 8 show the auto-injector 1000 in the same view as Figures 5 and 6, but in a later position during use of the auto-injector 1000. The plunger rod 1 is moving in the distal direction D by the energy provided by the drive spring 3. In Figures 7 and 8, the plunger rod 1 is in the interaction position and hits the stopper 82. When hitting the stopper 82, an impact is transmitted to the syringe 8. However, the initial distance between the plunger rod 1 and the stopper 82 in the initial state is selected such that the probability of damage to the syringe 8, in particular the cartridge 81, is reduced. For example, out of 10,000 such drug delivery devices, damage to the syringe 8 occurs at most in one.

[0136] The plunger rod 1 hits the stopper 82, pushing it in the distal direction D. The syringe 8 or needle 80 cannot be moved in the distal direction as they are held in place by the container holder elements 6a, 6b and the syringe holder 6c, respectively.

[0137] 9 and 10 show the auto-injector 1000 in the same view as in FIGS. 7 and 8, but in a later position during use. The plunger rod 1 is driven by the drive spring 3 and moves further in the distal direction D, thereby pushing the stopper 82 in the distal direction D as well. The drug contained in the cartridge 81 is thereby forced out of the syringe 8, through the needle 80 and into the body tissue. The plunger rod 1 has reached an end position and cannot be moved further in the distal direction D. In this exemplary embodiment, this end position is also the feedback position, in which the projection 23 and the recess 13 overlap each other non-rotatably and axially. This triggers or activates the feedback mechanism. In particular, this overlap allows the projection 23 to engage into the recess 13, and thus the resilient arm 22 with the projection 23 can be displaced from the respective first position to the second position. However, the resilient arm 22 in the second position no longer holds the indicator 21 in the first state. As a result of this, the indicator 21 is allowed to switch to a second state, which preferably occurs automatically, thereby producing an audible and / or tactile feedback, which indicates to the user the end of drug delivery.

[0138] 11 and 12 show a second exemplary embodiment of a drug delivery device 1000. These figures are the same as those of FIGS. 2 and 3. The drug delivery device is an automatic injector 1000. Moreover, in FIGS. 11 and 12, the automatic injector 1000 is also in an initial state. The automatic injector 1000 of the first and second exemplary embodiments is almost the same. The difference is that in the second exemplary embodiment, the syringe 8 is filled with a larger volume of drug. However, the geometry and dimensions of the syringe 8 are the same. In both exemplary embodiments, the geometry, dimensions and relative positions of the housing 100, the container holding area 6, the container holder elements 6a, 6b, the syringe holder 6c, the syringe 8, the drive spring holder 4, the indicator 21, the elastic arm 22 and the protrusion 23 are the same or substantially the same. In particular, only the plunger rod 1, the amount of drug in the syringe 8 and the starting position of the stopper 82 are different in the two exemplary embodiments.

[0139] The stopper 82 is located further proximally in the second exemplary embodiment than in the first exemplary embodiment, since a larger amount of drug is contained in the syringe 8. Accordingly, the length of the plunger rod 1 is selected to be smaller in the second exemplary embodiment than in the first exemplary embodiment, in order to maintain the initial distance between the plunger rod 1 and the stopper 82 in the initial state.

[0140] 13 and 14 are the same views as in FIGS. 11 and 12, but now show the auto-injector 1000 after it has been switched from the initial state to the released state and the plunger rod 1 has been moved by the drive spring 3 in the distal direction D to an end position. In a second exemplary embodiment, the trigger function 13 of the plunger rod 1 is formed by the proximal end of the plunger rod 1. As soon as the proximal end of the plunger rod 1 passes the projection 23 of the resilient arm 22, the resilient arm 22 is allowed to be displaced radially inwards, whereby the projection 23 is displaced into the space proximally behind the plunger rod 1. The indicator 21 switches from its first state to its second state and produces an audible and / or tactile feedback.

[0141] 15 and 16 show a third exemplary embodiment of a drug delivery device 1000, again in the same view as in FIG. 3 and FIG. 4. The drug delivery device 1000 of the third exemplary embodiment is again an automatic injector 1000. Again, the dimensions and relative positions of the housing 100, the syringe 8, the container holding area 6, the container holder elements 6a, 6b, the syringe holder 6c, the syringe 8, the drive spring holder 4, the indicator 21, the elastic arm 22 and the protrusion 23 are the same or substantially the same as in the first and second exemplary embodiments. The difference is again the fill volume of the drug contained in the syringe 8 and the design of the plunger rod 1. In the third exemplary embodiment, the fill volume is smaller than in the first exemplary embodiment. Accordingly, the stopper 82 is arranged further distally than in the first exemplary embodiment. As a result of this, the plunger rod 1 is selected to be longer than in the first exemplary embodiment. Again, the length of the plunger rod 1 is selected so that in the initial state, the plunger rod 1 is axially spaced from the stopper 82, but is sufficiently close to the stopper 82 to reduce the risk of damage to the syringe 8 or cartridge 81, respectively, when the plunger rod 1 hits the stopper 82 in the released state.

[0142] Figures 17 and 18 show the auto-injector 1000 of Figures 15 and 16 after it has been switched from an initial state to a release state and the plunger rod 1 has been driven by the drive spring 3 to an end position, which may be a feedback position. Again, the plunger rod 1 includes a recess 13 forming a trigger feature 13. In the feedback position, the recess 13 axially and non-rotatably overlaps the protrusion 23 of the resilient arm 22, allowing the protrusion 23 to engage into the recess 13, so that the resilient arm 22 can be displaced and the indicator 21 can be switched from its first state to its second state, thereby generating an audible and / or tactile feedback.

[0143] The difference between the plunger rod 1 of the first exemplary embodiment and the plunger rod 1 of the third exemplary embodiment is that in the third exemplary embodiment, the recess 13 does not axially overlap the protrusion 10. Instead, in the third exemplary embodiment, the recess 13 is offset in the distal direction D relative to the protrusion 10.

[0144] 19 and 20 show an exemplary embodiment of the indicator 21 in a first or biased state (FIG. 20) and a second or relaxed state (FIG. 21). The indicator 21 is a leaf spring 21, for example formed from a metal sheet. The leaf spring 21 is bent at a certain angle about a longitudinal axis X to form a longitudinal round fold 21a. Two inclined wing-like sections 21b are arranged on either side of the longitudinal round fold 21a. A notch 21c is formed in the leaf spring 21, i.e. in the longitudinal round fold 21a. The notch 21c can be provided to support consistency of priming, i.e. switching to the first (biased) state. In the biased state, the leaf spring 21 is bent about a transverse axis T extending perpendicular to the longitudinal axis X.

[0145] 21 and 22 show a proximal portion of an exemplary embodiment of the plunger rod 1 and the needle shroud 5. The plunger rod 1 and the needle shroud 5 may be of a first exemplary embodiment of the drug delivery device 1000. The plunger rod 1 includes an elongated recess 13 into which a protrusion 23 of the elastic arm 22 may engage when the plunger rod 1 is in a feedback position. The plunger rod 1 further includes a retaining structure 14. The retaining structure 14 is configured to couple to the drive spring holder 4 and the needle shroud 5 to establish an axial locking interface and a rotational locking interface. The retaining structure 14 includes a plurality of protrusions 10, 11, 12 protruding radially outward. The first protrusion 10 is configured to engage into a recess 24 of the drive spring holder 4 to establish an axial locking interface. The second protrusion 11 is configured to engage into a recess 50 (see FIG. 22) of the needle shroud 5 and abut an edge 51 that rotationally bounds the recess 50 to establish a rotation-locking interface. The third protrusion 12 can abut an inclined portion of the needle shroud 5 when the needle shroud is moved in the proximal direction P. This abutment can support or guide the rotation of the plunger rod 1. The protrusions 10, 11, 12 project radially outward and are axially and non-rotatably offset with respect to each other.

[0146] The projections 11, 12 and the recesses 50 are not shown in the above figures in order to increase the clarity of the drawings.

[0147] As can be seen in Fig. 22, the recess 50 includes two sections, a first section rotationally separated by an edge 51 and a second section disposed further distally than the first section and having a greater extent in the rotational direction. In an initial state, when the needle shroud 5 is in an extended position, the projection 11 projects into the first section and abuts the edge 51. When the needle shroud 5 is moved in the proximal direction P to its retracted position, the projection 11 axially overlaps the second section of the recess 50. This allows rotation of the plunger rod 1.

[0148] 23 shows an exemplary embodiment of a method for assembling a drug delivery device. A plurality of drug containers 8 in the form of syringes 8 are provided. All syringes 8 have the same or substantially the same outer dimensions, in particular the same or substantially the same diameter, and the same or substantially the same length. All syringes 8 may be made of the same material. However, the syringes 8 differ with respect to the amount of drug contained in each syringe 8. The more drug contained in the syringe 8, the further the stopper 82 is spaced from the needle 80.

[0149] Further, a set of plunger rods 1 is provided. All the plunger rods 1 have different lengths and all include a trigger feature 13 and a retaining structure 14 with several protrusions 10, 11, 12. In some of the plunger rods 1, the trigger feature 13 is an elongated recess 13, and in some plunger rods 1, the trigger feature 13 is the proximal end of the plunger rod 1. For all plunger rods 1, the distance between the distal end of the plunger rod 1 and the trigger feature 13 is the same or substantially the same. If the trigger feature 13 is a recess, this distance is measured, for example, from the distal end of the recess 13 to the distal end of the plunger rod 1.

[0150] The retaining structures 14 of the different plunger rods are the same or substantially the same for all plunger rods 1. In particular, the relative positions between the protrusions 10, 11, 12 and the dimensions of the protrusions 10, 11, 12 are the same or substantially the same for all plunger rods 1. Depending on the length of the plunger rod 1, the retaining structure 14 is offset in a proximal direction P relative to the trigger feature 13, or axially overlaps the trigger feature 13, or is offset in a distal direction D relative to the trigger feature 13. In some plunger rods 1, the trigger feature 13 does not axially overlap the retaining structure 14.

[0151] In the first step of the method, a syringe 8 with a desired amount of drug is selected. Then, depending on the selected syringe 8, a plunger rod 1 is selected from a set of plunger rods. The selected plunger rod 1 and the selected syringe 8 are then used to assemble a drug delivery device 1000. At the bottom of FIG. 23, a set of drug delivery devices 1000 thus assembled is shown. As can be seen, most of the dimensions of the components and the relative positions between the components are the same for all drug delivery devices 1000. In particular, the position of the protrusion 23 relative to the container holding area 6 and / or the container holder elements 6a, 6b is the same for all drug delivery devices 1000.

[0152] 24 shows a second exemplary embodiment of a set of plunger rods. One plunger rod 1 (the central one) includes a trigger feature 13 in the form of an elongated recess that is not bounded in the proximal direction P by an edge of the plunger rod 1.

[0153] Further Explanations and Definitions The terms "drug" or "medicament" are used interchangeably herein to describe a pharmaceutical formulation containing one or more active pharmaceutical ingredients or their pharma- ceutically acceptable salts or solvates, and optionally a pharma- ceutically 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 medicines are used to treat, cure, prevent, or diagnose diseases or otherwise improve physical or mental well-being. Drugs or medicines can be used for a limited duration or periodically for chronic disorders.

[0154] As described below, drugs or agents may include at least one API or combinations thereof in various types of formulations for the treatment of one or more diseases. Examples of APIs may include small molecules with molecular weights of 500 Da or less, polypeptides, peptides, and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes), carbohydrates and polysaccharides, as well as nucleic acids, double-stranded or single-stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids may be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also contemplated.

[0155] 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 be at room temperature (e.g., about 20° C.) or at refrigerated temperatures (e.g., from about −4° C. to about 4° C.). In some cases, the drug container 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.

[0156] The drugs or agents contained in the drug delivery devices described herein can be used for the treatment and / or prevention of many different types of medical disorders. Examples of disorders include, for example, diabetes or complications associated with diabetes, such as diabetic retinopathy, thromboembolic disorders, such as deep vein thromboembolism or pulmonary thromboembolism. Further examples of disorders are acute coronary syndromes (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis. Examples of APIs and drugs are those found in handbooks such as Rote Liste 2014 (e.g., but not limited to, main groups 12 (antidiabetic agents) or 86 (oncology agents)) and the Merck Index, 15th edition.

[0157] 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, analog or derivative thereof, a dipeptidyl peptidase-4 (DPP4) inhibitor, or a pharma-ceutically 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. The added and / or replaced amino acid residue can be either a codable amino acid residue or another naturally occurring residue or a purely synthetic amino acid residue. Insulin analogs are also referred to as "insulin receptor ligands". In particular, the term "derivative" refers to a polypeptide having a molecular structure formally derivable from the structure of a naturally occurring peptide, e.g., the molecular structure of human insulin in which one or more organic substituents (e.g., fatty acids) are attached to one or more of the amino acids. Optionally, one or more amino acids present in the naturally occurring peptide are deleted and / or replaced by other amino acids, including non-codeable amino acids, or amino acids, including non-codeable ones, are added to the naturally occurring peptide.

[0158] Examples of insulin analogues are Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); human insulin in which the proline in position B28 may be replaced by Asp, Lys, Leu, Val or Ala and in which the Lys in 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.

[0159] Examples of insulin derivatives are e.g. B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir®); B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl-LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin. ; 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.

[0160] 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 (efpegrenatide). , HM-15211, CM-3, GLP-1 Erigen, ORMD-0901, NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, Nodexene, Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR709, ZP-2929, ZP-3022, ZP -DI-70, TT-401 (Pegapamodtide), BHM-034, MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, Tirzepatide (LY3298176), Bamadutide (SAR425899), Exenatide-XTEN and Glucagon-Xten.

[0161] Examples of oligonucleotides are, for example, the cholesterol-lowering antisense therapeutic mipomersen sodium (Kynamro®) for the treatment of familial hypercholesterolemia, or RG012 for the treatment of Alport Syndrome.

[0162] Examples of DPP4 inhibitors are linagliptin, vidagliptin, sitagliptin, denagliptin, saxagliptin, berberine.

[0163] 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.

[0164] Examples of polysaccharides include glycosaminoglycans, hyaluronic acid, heparin, low molecular weight heparin or very low molecular weight heparin or derivatives thereof, or sulfated polysaccharides, such as the above-mentioned polysaccharides in polysulfated form, and / or their pharma- ceutically acceptable salts. An example of a pharma-ceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan G-F20 (Synvisc®), sodium hyaluronate.

[0165] The term "antibody" as used herein refers to an immunoglobulin molecule or an antigen-binding portion thereof. Examples of antigen-binding portions of an immunoglobulin molecule include F(ab) and F(ab')2 fragments that retain the ability to bind to an antigen. An antibody can be a polyclonal antibody, a monoclonal antibody, a recombinant antibody, a chimeric antibody, a deimmunized or humanized antibody, a fully human antibody, a non-human (e.g., murine) antibody, or a single chain antibody. In some embodiments, an antibody has effector 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, an antibody fragment, or a mutant that does not support binding to Fc receptors, e.g., with a mutation or deletion of the Fc receptor binding region. The term antibody also includes antigen-binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTI) and / or dual variable region antibody-like binding proteins (CODV) with crossover binding region orientation.

[0166] The term "fragment" or "antibody fragment" refers to a polypeptide (e.g., antibody heavy and / or light chain polypeptide) derived from an antibody polypeptide molecule that does not include the full-length antibody polypeptide but comprises at least a portion of the full-length antibody polypeptide that is still capable of binding to an antigen. An antibody fragment 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, such as bispecific, trispecific, tetraspecific and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent or multivalent antibody fragments, such as bivalent, trivalent, tetravalent and multivalent antibodies, minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camelized antibodies, and VHH-containing antibodies. Additional examples of antigen-binding antibody fragments are known in the art.

[0167] The term "complementarity determining region" or "CDR" refers to short polypeptide sequences in 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 in the variable regions of both heavy and light chain polypeptides that are not CDR sequences and are primarily responsible for maintaining the proper arrangement of the CDR sequences to allow antigen binding. Although the framework region itself typically does not directly participate in antigen binding, as is known in the art, certain residues in the framework region of a particular antibody may be directly involved in antigen binding or may affect the ability of one or more amino acids in the CDR to interact with the antigen.

[0168] Exemplary antibodies are anti-PCSK-9 mAb (eg, alirocumab), anti-IL-6 mAb (eg, sarilumab), and anti-IL-4 mAb (eg, dupilumab).

[0169] Pharmaceutically acceptable salts of any of the APIs described herein are contemplated for use in the drug or medicament in the drug delivery device. Pharmaceutically acceptable salts include, for example, acid addition salts and base salts.

[0170] It will be understood by those skilled in the art that modifications (additions and / or deletions) can be made to the various components of the APIs, formulations, apparatus, methods, systems, and embodiments described herein without departing from the full scope and spirit of the invention, and that the invention encompasses such modifications and all equivalents thereof.

[0171] An exemplary drug delivery device may involve a needle-based injection system as described in Table 1 of Chapter 5.2 of ISO11608-1:2014(E). As described in ISO11608-1:2014(E), needle-based injection systems can be broadly differentiated into multi-dose container systems and single-dose (partial or full expulsion) container systems. The container may be an exchangeable container or an integrated non-exchangeable container.

[0172] As further described in ISO11608-1:2014(E), a multi-dose container system can involve a needle-based injection device with an exchangeable container. In such a system, each container holds multiple doses and the dose size can be fixed or variable (pre-set by the user). Another multi-dose container system can involve a needle-based injection device with an integrated non-exchangeable container. In such a system, each container holds multiple doses and the dose size can be fixed or variable (pre-set by the user).

[0173] As further described in ISO11608-1:2014(E), the single-dose container system can involve a needle-based injection device with a replaceable container. In one example of such a system, each container holds a single dose, thereby discharging the entire deliverable volume (full discharge). In a further example, each container holds a single dose, thereby discharging a portion of the deliverable volume (partial discharge). As also described in ISO11608-1:2014(E), the single-dose container system can involve a needle-based injection device with an integrated non-replaceable container. In one example of such a system, each container holds a single dose, thereby discharging the entire deliverable volume (full discharge). In a further example, each container holds a single dose, thereby discharging a portion of the deliverable volume (partial discharge).

[0174] The invention described herein is not limited by the description in relation to the exemplary embodiments, but rather includes any novel configuration and any combination of configurations, and in particular any combination of configurations in the claims, even if such configuration or such combination is not itself explicitly recited in the claims or in the exemplary embodiments. [Explanation of symbols]

[0175] 1 Plunger Rod 3 Drive spring 4 Drive spring holder 5 Needle Shroud 6 Container holding area 6a Container holder element 6b Container holder element 6c Drug Container Holder / Syringe Holder 8 Drug containers / syringes 8a Flange 10 protrusions 11 Protrusions 12 protrusions 13 Trigger function 14 Retention structure 21 Indicator / Leaf spring 21a Longitudinal rounded fold 21b Feathered Section 21c notch 22 Support elements 23 Operational Functions 24 Recess 80 needles 81 Cartridge 82 Stopper 100 Housing 110 Cap 120 Window 1000 Drug Delivery Device D Distal direction P Proximal direction A Longitudinal axis R Radial direction C Azimuth direction / Rotation direction / Angle direction X Longitudinal Axis T transverse axis

Claims

1. A drug delivery device (1000), comprising: a housing (100) configured to receive a drug container (8), the stopper (82) sealing the drug container (8) proximally; a plunger rod (1) disposed axially movably relative to the housing (100) and / or the drug container (8); a feedback mechanism operably coupled to the plunger rod (1), wherein the drug delivery device (1000) has an initial state in which the plunger rod (1) is in its starting position, the drug delivery device (1000) in the initial state, when the drug container (8) is received within the housing (100), the plunger rod (1) is axially spaced from the stopper (82); the plunger rod (1) is axially movable from its starting position in the distal direction (D) to a feedback position; the movement of the plunger rod (1) in the distal direction (D) enables the plunger rod (1) to interact with the stopper (82) and push the stopper (82) in the distal direction (D), thereby delivering the drug stored within the drug container (8); when the plunger rod (1) reaches the feedback position, the feedback mechanism is triggered; the triggering of the feedback mechanism is configured to generate an audible and / or tactile feedback indicating the end of drug delivery.

2. When the drug container (8) is received within the housing (100), the drug delivery device (1000) the plunger rod (1) is movable a distance in the distal direction (D) from its starting position before interacting with the stopper (82), and after being moved by the distance, the plunger rod (1) interacts with the stopper (82) until it reaches the feedback position; in the initial state, the initial distance between the plunger rod (1) and the stopper (82) is selected such that the probability of damage to the drug container (8) when the plunger rod (1) interacts with the stopper (82) is reduced; The drug delivery device (1000) according to claim 1, wherein the initial distance between the plunger rod (1) and the stopper (82) is selected to take into account manufacturing tolerances and / or assembly tolerances and / or distance variations due to vibrations occurring during transportation of the drug delivery device (1000).

3. In the initial state, the initial distance between the plunger rod (1) and the stopper (82) is selected to take into account manufacturing tolerances and / or assembly tolerances and / or distance variations due to vibrations occurring during transportation of the drug delivery device (1000). The drug delivery device (1000) according to claim 1 or 2.

4. The feedback mechanism includes an indicator (21) having a first state and a second state, The drug delivery device (1000) is configured such that when the feedback mechanism is triggered, the indicator (21) switches from the first state to the second state, thereby producing an audible and / or tactile feedback, Optionally, the indicator (21) is an elastic element, in particular a leaf spring. The drug delivery device (1000) according to any one of claims 1 to 3.

5. The feedback mechanism includes a trigger function (13) axially fixed to the plunger rod (1), The feedback mechanism includes an operating function (23) axially fixed to the housing (100), At least one of the trigger function (13) and the operating function (23) is displaceable, The drug delivery device (1000) is configured such that when the plunger rod (1) is moved from its starting position to the feedback position, the trigger function (13) and the operating function (23) axially pass through each other or at least axially overlap each other, thereby enabling the displaceable function to be displaced to trigger the feedback mechanism. The drug delivery device (1000) according to any one of claims 1 to 4.

6. The operating function (23) is a protrusion, The trigger function (13) is a recess in the plunger rod (1) or the proximal end of the plunger rod (1), When the plunger rod (1) reaches the feedback position, the protrusion displaces into the recess (13) or into the space behind the proximal end of the plunger rod (1). The drug delivery device (1000) according to claim 5.

7. The feedback mechanism includes a support element (22) that provides mechanical support to the indicator (21) to hold the indicator (21) in the first state until the plunger rod (1) reaches the feedback position, The mechanical support for holding the indicator (21) in the first state is released when the plunger rod (1) reaches the feedback position, and thus the indicator (21) is enabled to switch to the second state. The drug delivery device (1000) according to claim 4 or claim 5 or 6 depending on claim 4.

8. The plunger rod (1) is rotatably arranged relative to the housing (100), In the initial state, the plunger rod (1) is connected to the housing (100) by an axial locking interface that prevents axial movement of the plunger rod (1) in the distal direction (D), The drug delivery device (1000) is configured such that rotation of the plunger rod (1) relative to the housing (100) releases the axial locking interface and enables movement of the plunger rod (1) in the distal direction (D). The drug delivery device (1000) according to any one of claims 1 to 7.

9. Further comprising an energy member (3) configured to provide energy for inducing axial movement of the plunger rod (1) in the distal direction (D), The drug delivery device (1000) is configured to be switched from an initial state to a released state, and in the released state, the plunger rod (1) moves in the distal direction (D) by the energy provided by the energy member (3). The drug delivery device (1000) according to any one of claims 1 to 8.

10. Further comprising a release member (5) movably arranged axially relative to the housing (100), When the drug delivery device (1000) is in the initial state, movement of the release member (5) in the axial direction enables rotation of the plunger rod (1) and releases the axial locking interface. The drug delivery device (1000) according to claim 8 or claim 9 dependent on claim 8.

11. In the initial state, the release member (5) is in an extended position and covers the drug delivery element (80) of the drug container (8), Movement of the release member (5) in the axial direction to a retracted position enables rotation of the plunger rod (1), The retracted position is a position that exposes the drug delivery element (80). The drug delivery device (1000) according to claim 10.

12. The drug delivery device (1000) includes a drug container (8), and the drug container (8) contains a drug. The drug delivery device (1000) according to any one of claims 1 to 11.

13. A set of plunger rods for a drug delivery device, Each plunger rod (1) of the set of plunger rods is configured to enable the trigger of the audible and / or tactile feedback mechanism of the drug delivery device when the plunger rod (1) is assembled within the drug delivery device and the trigger function (13) axially passes through or at least axially overlaps the operating function (23) of the feedback mechanism. Each plunger rod (1) has a distal end. At least some of the plunger rods (1) of the set of plunger rods have different lengths. The set of plunger rods, wherein the distance between the distal end and the trigger function (13) is the same or substantially the same for all plunger rods (1). **Claim 14** A method of assembling a drug delivery device (1000), comprising: providing a drug container (8) containing a drug that occupies a filling volume within the drug container (8); selecting a plunger rod (1) from the set of plunger rods according to claim 13 according to the filling volume; assembling the drug delivery device (1000) by using the drug container (8) and the selected plunger rod (1). **Claim 15** A set of drug delivery devices (1000), comprising: each drug delivery device (1000) of the set of drug delivery devices includes a plunger rod (1) of the set of plunger rods according to claim 13; each drug delivery device (1000) includes an audible and / or tactile feedback mechanism having an operating function (23); each drug delivery device (1000) includes a container holding region (6) configured to receive a drug container; at least some of the drug delivery devices (1000) of the set of drug delivery devices include plunger rods (1) having different lengths; the set of drug delivery devices, wherein the position of the operating function (23) relative to the container holding region (6) is the same or substantially the same for each drug delivery device (1000). ​

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